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High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department

High Dose Intravenous Lidocaine vs Hydromorphone for Acute Abdominal Pain in the Emergency Department: A Randomized, Comparative Efficacy Trial

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04398316
Acronym
HIDO-LIDO
Enrollment
4
Registered
2020-05-21
Start date
2021-02-18
Completion date
2021-06-30
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Renal Colic

Keywords

lidocaine, hydromorphone, abdominal pain

Brief summary

Intravenous lidocaine will be given at a dose of 2 mg/kg intravenously to patients in the emergency department with a diagnosis of acute abdominal pain. Its efficacy will be compared to 1 mg of intravenous hydromorphone, with a primary endpoint of mean improvement of pain at 90 minutes.

Detailed description

Abdominal pain is a common chief complaint for patients presenting to the emergency department (ED) in the United States. Intravenous opioids are commonly used to treat acute abdominal pain in the ED. These medications are highly efficacious and, when used in a monitored setting such as the ED, extremely safe. Use of opioids has fallen out of favor because of a spike in opioid-related overdose deaths throughout the United States. While use of opioids in the ED is unlikely to contribute to outpatient opioid deaths, minimizing the use of opioids in the ED will contribute to an opioid free culture, in which opioids are used only when absolutely necessary. A variety of different types of medications can be used in lieu of opioids. One such medication, intravenous lidocaine, has been used extensively for neuropathic pain, in the peri- and post-operative surgical setting, the cardiac care unit, and most recently in the emergency department. Intravenous lidocaine has long been used to treat pain. In publications dating back to 1980, intravenous lidocaine has been shown to be an effective treatment for neuropathic pain. In the postoperative setting, intravenous lidocaine decreased pain and decreased the need for opiates. More recently, emergency medicine investigators in Iran demonstrated that intravenous lidocaine decreased pain associated with renal colic and limb ischemia. An ED-based study in the United States showed comparable efficacy between morphine and intravenous lidocaine when used for acute pain. Most recently, a prospective RCT showed 120 mg of intravenous lidocaine was efficacious for abdominal pain, albeit not as effective as 1 mg of hydromorphone. However, a subgroup analysis showed that when lidocaine was dosed at 2 mg/kg, it was equally as effective as hydromorphone. Over the years, intravenous lidocaine has been used for a variety of indications including arrhythmia prophylaxis in patients with acute coronary syndromes. Known side effects of intravenous lidocaine range from transient neurological symptoms (dizziness, paresthesias), to cardiac dysrhythmias and seizure. To date, no deaths have been attributed to its use for treating pain, and the only documented significant complication was due to an unintentional overdose when a patient received ten times the normal dose. All reported side effects in pain patients have been transient and resolved by either stopping the drug, decreasing the infusion rate or by observation alone. Additionally, doses of 2 mg/kg have been tolerated well in the outpatient setting, operating room and ED without any serious side effects. Thus, intravenous lidocaine is an emerging medication for safe and rapid relief of pain, has no known addictive properties, and creates a potential for a pain practice paradigm shift in the United States. We therefore propose a randomized, double blind, comparative efficacy trial to address the following aim: To determine if a 2 mg/kg dose of intravenous lidocaine is as equally efficacious as a single dose of 1 mg intravenous hydromorphone for acute abdominal pain in the emergency department.

Interventions

DRUGLidocaine Iv

2 mg/kg over 5 minutes

DRUGHYDROmorphone Injection

1 mg over 5 minutes

Sponsors

Hennepin Healthcare Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Must be a patient in the emergency department (ED) * Must have acute abdominal pain, defined as abdominal or flank pain of a duration of 7 days or less * Predicted treatment must include the use of an intravenous opiate

Exclusion criteria

* Cardiac conduction system impairment (QTc duration \> 0.5s, QRS duration \> 0.12s, PR interval \<0.12s or \> 0.2s) * Known renal (CKD \>2) or liver disease (Childs-Pugh B or greater) * Hemodynamically instability, defined by the attending physician * Pregnant or breastfeeding * Have a known allergy to either medication * Used of prescription or illicit opioids within the previous week * Patients with a chronic pain disorder, defined as use of any analgesic medication on more days than not during the four weeks preceding the acute episode of pain

Design outcomes

Primary

MeasureTime frameDescription
Mean Improvement in Pain at 90 Minutes90 minutesThe difference between the pain score at time 0 and 90 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

Secondary

MeasureTime frameDescription
Improvement in Numerical Pain Score at 15 Minutes15 minutesThe difference between the pain score at time 0 and 15 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Improvement in Numerical Pain Score at 30 Minutes30 minutesThe difference between the pain score at time 0 and 30 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Improvement in Numerical Pain Score at 60 Minutes60 minutesThe difference between the pain score at time 0 and 60 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Improvement in Numerical Pain Score at 120 Minutes120 minutesThe difference between the pain score at time 0 and 120 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Improvement in Numerical Pain Score at 150 Minutes150 minutesThe difference between the pain score at time 0 and 150 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Improvement in Numerical Pain Score at 180 Minutes180 minutesThe difference between the pain score at time 0 and 180 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Sufficient Pain ReliefFrom administration of study drug until patient leaves the emergency department, up until 3 hours from administration of study drug.Does the patient require off-protocol medication for additional pain relief? Off-protocol defined as any opiate or NSAID
Side Effects15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes and at 7 daysYes or no, did the patient have any side effects, defined as any new symptom after the administration of the study drug.
Medication for Side Effects15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutesAre any medications required to control medication side effects, defined as any new symptom after the administration of the study drug?
Administration of Naloxone15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutesYes or no, was naloxone required after the patient received the study drug?
Change in Disposition15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutesYes or no, did the patients disposition change as a consequence of administration of the study drug? Example would be an adverse outcome resulting in hospitalization or other escalation of care.
Missed Diagnosis7 days after administration of study drugYes or no, did the patient have a new diagnosis within the next week?
Serious Adverse Event180 minutes after administration of study drugYes or no, did the patient suffer a serious adverse event? Defined as death, requiring or prolonging inpatient hospitalization, resulting in persistent or significant disability/incapacity, or is considered a significant medical event by the investigator based off of medical judgement.
Patient Preference for the Medication They ReceivedDay 7If the patient were to come to the ED again for the same complaint, would they want the same study drug they received?

Countries

United States

Participant flow

Participants by arm

ArmCount
Intravenous Lidocaine
Administered at a dose of 2 mg/kg over 5 minutes Lidocaine Iv: 2 mg/kg over 5 minutes
3
Intravenous Hydromorphone
Administered at a dose of 1 mg over 5 minutes HYDROmorphone Injection: 1 mg over 5 minutes
1
Total4

Baseline characteristics

CharacteristicIntravenous LidocaineIntravenous HydromorphoneTotal
Age, Continuous37.33 years
STANDARD_DEVIATION 13.58
61 years
STANDARD_DEVIATION 0
43.25 years
STANDARD_DEVIATION 16.21
Race/Ethnicity, Customized
Race
American Indian (Native American) or Alaskan Native
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race
Black (African American or African)
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race
White (Caucasian, Non-Hispanic)
1 Participants1 Participants2 Participants
Sex: Female, Male
Female
2 Participants0 Participants2 Participants
Sex: Female, Male
Male
1 Participants1 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 30 / 1
other
Total, other adverse events
3 / 30 / 1
serious
Total, serious adverse events
0 / 30 / 1

Outcome results

Primary

Mean Improvement in Pain at 90 Minutes

The difference between the pain score at time 0 and 90 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

Time frame: 90 minutes

ArmMeasureValue (MEAN)Dispersion
Intravenous LidocaineMean Improvement in Pain at 90 Minutes3.67 score on a scaleStandard Deviation 3.51
Intravenous HydromorphoneMean Improvement in Pain at 90 Minutes-1 score on a scaleStandard Deviation 0
Secondary

Administration of Naloxone

Yes or no, was naloxone required after the patient received the study drug?

Time frame: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intravenous LidocaineAdministration of NaloxoneYes0 Participants
Intravenous LidocaineAdministration of NaloxoneNo3 Participants
Intravenous HydromorphoneAdministration of NaloxoneNo1 Participants
Intravenous HydromorphoneAdministration of NaloxoneYes0 Participants
Secondary

Change in Disposition

Yes or no, did the patients disposition change as a consequence of administration of the study drug? Example would be an adverse outcome resulting in hospitalization or other escalation of care.

Time frame: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intravenous LidocaineChange in DispositionYes0 Participants
Intravenous LidocaineChange in DispositionNo3 Participants
Intravenous HydromorphoneChange in DispositionYes0 Participants
Intravenous HydromorphoneChange in DispositionNo1 Participants
Secondary

Improvement in Numerical Pain Score at 120 Minutes

The difference between the pain score at time 0 and 120 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

Time frame: 120 minutes

ArmMeasureValue (MEAN)Dispersion
Intravenous LidocaineImprovement in Numerical Pain Score at 120 Minutes4 score on a scaleStandard Deviation 3
Intravenous HydromorphoneImprovement in Numerical Pain Score at 120 Minutes-2 score on a scaleStandard Deviation 0
Secondary

Improvement in Numerical Pain Score at 150 Minutes

The difference between the pain score at time 0 and 150 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

Time frame: 150 minutes

ArmMeasureValue (MEAN)Dispersion
Intravenous LidocaineImprovement in Numerical Pain Score at 150 Minutes3.33 score on a scaleStandard Deviation 2.08
Intravenous HydromorphoneImprovement in Numerical Pain Score at 150 Minutes-2 score on a scaleStandard Deviation 0
Secondary

Improvement in Numerical Pain Score at 15 Minutes

The difference between the pain score at time 0 and 15 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

Time frame: 15 minutes

ArmMeasureValue (MEAN)Dispersion
Intravenous LidocaineImprovement in Numerical Pain Score at 15 Minutes4.33 score on a scaleStandard Deviation 3.51
Intravenous HydromorphoneImprovement in Numerical Pain Score at 15 Minutes0 score on a scaleStandard Deviation 0
Secondary

Improvement in Numerical Pain Score at 180 Minutes

The difference between the pain score at time 0 and 180 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

Time frame: 180 minutes

ArmMeasureValue (MEAN)Dispersion
Intravenous LidocaineImprovement in Numerical Pain Score at 180 Minutes3.33 score on a scaleStandard Deviation 2.08
Intravenous HydromorphoneImprovement in Numerical Pain Score at 180 Minutes-2 score on a scaleStandard Deviation 0
Secondary

Improvement in Numerical Pain Score at 30 Minutes

The difference between the pain score at time 0 and 30 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

Time frame: 30 minutes

ArmMeasureValue (MEAN)Dispersion
Intravenous LidocaineImprovement in Numerical Pain Score at 30 Minutes2.33 score on a scaleStandard Deviation 1.53
Intravenous HydromorphoneImprovement in Numerical Pain Score at 30 Minutes1 score on a scaleStandard Deviation 0
Secondary

Improvement in Numerical Pain Score at 60 Minutes

The difference between the pain score at time 0 and 60 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

Time frame: 60 minutes

ArmMeasureValue (MEAN)Dispersion
Intravenous LidocaineImprovement in Numerical Pain Score at 60 Minutes4 score on a scaleStandard Deviation 3
Intravenous HydromorphoneImprovement in Numerical Pain Score at 60 Minutes1 score on a scaleStandard Deviation 0
Secondary

Medication for Side Effects

Are any medications required to control medication side effects, defined as any new symptom after the administration of the study drug?

Time frame: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Intravenous LidocaineMedication for Side Effects30 MinutesProchlorperazine0 Participants
Intravenous LidocaineMedication for Side Effects15 MinutesDiphenhydramine0 Participants
Intravenous LidocaineMedication for Side Effects15 MinutesOndansetron0 Participants
Intravenous LidocaineMedication for Side Effects15 MinutesMetoclopramide0 Participants
Intravenous LidocaineMedication for Side Effects15 MinutesDroperidol0 Participants
Intravenous LidocaineMedication for Side Effects15 MinutesPromethazine0 Participants
Intravenous LidocaineMedication for Side Effects15 MinutesProchlorperazine0 Participants
Intravenous LidocaineMedication for Side Effects15 MinutesOther0 Participants
Intravenous LidocaineMedication for Side Effects30 MinutesNone3 Participants
Intravenous LidocaineMedication for Side Effects30 MinutesDiphenhydramine0 Participants
Intravenous LidocaineMedication for Side Effects30 MinutesOndansetron0 Participants
Intravenous LidocaineMedication for Side Effects30 MinutesMetoclopramide0 Participants
Intravenous LidocaineMedication for Side Effects30 MinutesDroperidol0 Participants
Intravenous LidocaineMedication for Side Effects30 MinutesPromethazine0 Participants
Intravenous LidocaineMedication for Side Effects15 MinutesNone3 Participants
Intravenous LidocaineMedication for Side Effects30 MinutesOther0 Participants
Intravenous LidocaineMedication for Side Effects60 MinutesNone3 Participants
Intravenous LidocaineMedication for Side Effects60 MinutesDiphenhydramine0 Participants
Intravenous LidocaineMedication for Side Effects60 MinutesOndansetron0 Participants
Intravenous LidocaineMedication for Side Effects60 MinutesMetoclopramide0 Participants
Intravenous LidocaineMedication for Side Effects60 MinutesDroperidol0 Participants
Intravenous LidocaineMedication for Side Effects60 MinutesPromethazine0 Participants
Intravenous LidocaineMedication for Side Effects60 MinutesProchlorperazine0 Participants
Intravenous LidocaineMedication for Side Effects60 MinutesOther0 Participants
Intravenous LidocaineMedication for Side Effects90 MinutesNone2 Participants
Intravenous LidocaineMedication for Side Effects90 MinutesDiphenhydramine1 Participants
Intravenous LidocaineMedication for Side Effects90 MinutesOndansetron0 Participants
Intravenous LidocaineMedication for Side Effects90 MinutesMetoclopramide0 Participants
Intravenous LidocaineMedication for Side Effects90 MinutesDroperidol0 Participants
Intravenous LidocaineMedication for Side Effects90 MinutesPromethazine0 Participants
Intravenous LidocaineMedication for Side Effects90 MinutesProchlorperazine0 Participants
Intravenous LidocaineMedication for Side Effects90 MinutesOther0 Participants
Intravenous LidocaineMedication for Side Effects120 MinutesNone3 Participants
Intravenous LidocaineMedication for Side Effects120 MinutesDiphenhydramine0 Participants
Intravenous LidocaineMedication for Side Effects120 MinutesOndansetron0 Participants
Intravenous LidocaineMedication for Side Effects120 MinutesMetoclopramide0 Participants
Intravenous LidocaineMedication for Side Effects120 MinutesDroperidol0 Participants
Intravenous LidocaineMedication for Side Effects120 MinutesPromethazine0 Participants
Intravenous LidocaineMedication for Side Effects120 MinutesProchlorperazine0 Participants
Intravenous LidocaineMedication for Side Effects120 MinutesOther0 Participants
Intravenous LidocaineMedication for Side Effects150 MinutesNone3 Participants
Intravenous LidocaineMedication for Side Effects150 MinutesDiphenhydramine0 Participants
Intravenous LidocaineMedication for Side Effects150 MinutesOndansetron0 Participants
Intravenous LidocaineMedication for Side Effects150 MinutesMetoclopramide0 Participants
Intravenous LidocaineMedication for Side Effects150 MinutesDroperidol0 Participants
Intravenous LidocaineMedication for Side Effects150 MinutesPromethazine0 Participants
Intravenous LidocaineMedication for Side Effects150 MinutesProchlorperazine0 Participants
Intravenous LidocaineMedication for Side Effects150 MinutesOther0 Participants
Intravenous LidocaineMedication for Side Effects180 MinutesNone3 Participants
Intravenous LidocaineMedication for Side Effects180 MinutesDiphenhydramine0 Participants
Intravenous LidocaineMedication for Side Effects180 MinutesOndansetron0 Participants
Intravenous LidocaineMedication for Side Effects180 MinutesMetoclopramide0 Participants
Intravenous LidocaineMedication for Side Effects180 MinutesDroperidol0 Participants
Intravenous LidocaineMedication for Side Effects180 MinutesPromethazine0 Participants
Intravenous LidocaineMedication for Side Effects180 MinutesProchlorperazine0 Participants
Intravenous LidocaineMedication for Side Effects180 MinutesOther0 Participants
Intravenous HydromorphoneMedication for Side Effects180 MinutesDroperidol0 Participants
Intravenous HydromorphoneMedication for Side Effects15 MinutesNone1 Participants
Intravenous HydromorphoneMedication for Side Effects90 MinutesDroperidol0 Participants
Intravenous HydromorphoneMedication for Side Effects15 MinutesDiphenhydramine0 Participants
Intravenous HydromorphoneMedication for Side Effects150 MinutesOndansetron0 Participants
Intravenous HydromorphoneMedication for Side Effects15 MinutesOndansetron0 Participants
Intravenous HydromorphoneMedication for Side Effects90 MinutesPromethazine0 Participants
Intravenous HydromorphoneMedication for Side Effects15 MinutesMetoclopramide0 Participants
Intravenous HydromorphoneMedication for Side Effects180 MinutesDiphenhydramine0 Participants
Intravenous HydromorphoneMedication for Side Effects15 MinutesDroperidol0 Participants
Intravenous HydromorphoneMedication for Side Effects90 MinutesProchlorperazine0 Participants
Intravenous HydromorphoneMedication for Side Effects15 MinutesPromethazine0 Participants
Intravenous HydromorphoneMedication for Side Effects150 MinutesMetoclopramide0 Participants
Intravenous HydromorphoneMedication for Side Effects15 MinutesProchlorperazine0 Participants
Intravenous HydromorphoneMedication for Side Effects90 MinutesOther0 Participants
Intravenous HydromorphoneMedication for Side Effects15 MinutesOther0 Participants
Intravenous HydromorphoneMedication for Side Effects180 MinutesProchlorperazine0 Participants
Intravenous HydromorphoneMedication for Side Effects30 MinutesNone1 Participants
Intravenous HydromorphoneMedication for Side Effects120 MinutesNone1 Participants
Intravenous HydromorphoneMedication for Side Effects30 MinutesDiphenhydramine0 Participants
Intravenous HydromorphoneMedication for Side Effects150 MinutesDroperidol0 Participants
Intravenous HydromorphoneMedication for Side Effects30 MinutesOndansetron0 Participants
Intravenous HydromorphoneMedication for Side Effects120 MinutesDiphenhydramine0 Participants
Intravenous HydromorphoneMedication for Side Effects30 MinutesMetoclopramide0 Participants
Intravenous HydromorphoneMedication for Side Effects180 MinutesOndansetron0 Participants
Intravenous HydromorphoneMedication for Side Effects30 MinutesDroperidol0 Participants
Intravenous HydromorphoneMedication for Side Effects120 MinutesOndansetron0 Participants
Intravenous HydromorphoneMedication for Side Effects30 MinutesPromethazine0 Participants
Intravenous HydromorphoneMedication for Side Effects150 MinutesPromethazine0 Participants
Intravenous HydromorphoneMedication for Side Effects30 MinutesProchlorperazine0 Participants
Intravenous HydromorphoneMedication for Side Effects120 MinutesMetoclopramide0 Participants
Intravenous HydromorphoneMedication for Side Effects30 MinutesOther0 Participants
Intravenous HydromorphoneMedication for Side Effects180 MinutesPromethazine0 Participants
Intravenous HydromorphoneMedication for Side Effects60 MinutesNone1 Participants
Intravenous HydromorphoneMedication for Side Effects120 MinutesDroperidol0 Participants
Intravenous HydromorphoneMedication for Side Effects60 MinutesDiphenhydramine0 Participants
Intravenous HydromorphoneMedication for Side Effects150 MinutesProchlorperazine0 Participants
Intravenous HydromorphoneMedication for Side Effects60 MinutesOndansetron0 Participants
Intravenous HydromorphoneMedication for Side Effects120 MinutesPromethazine0 Participants
Intravenous HydromorphoneMedication for Side Effects60 MinutesMetoclopramide0 Participants
Intravenous HydromorphoneMedication for Side Effects180 MinutesMetoclopramide0 Participants
Intravenous HydromorphoneMedication for Side Effects60 MinutesDroperidol0 Participants
Intravenous HydromorphoneMedication for Side Effects120 MinutesProchlorperazine0 Participants
Intravenous HydromorphoneMedication for Side Effects60 MinutesPromethazine0 Participants
Intravenous HydromorphoneMedication for Side Effects150 MinutesOther0 Participants
Intravenous HydromorphoneMedication for Side Effects60 MinutesProchlorperazine0 Participants
Intravenous HydromorphoneMedication for Side Effects120 MinutesOther0 Participants
Intravenous HydromorphoneMedication for Side Effects60 MinutesOther0 Participants
Intravenous HydromorphoneMedication for Side Effects180 MinutesOther0 Participants
Intravenous HydromorphoneMedication for Side Effects90 MinutesNone1 Participants
Intravenous HydromorphoneMedication for Side Effects150 MinutesNone1 Participants
Intravenous HydromorphoneMedication for Side Effects90 MinutesDiphenhydramine0 Participants
Intravenous HydromorphoneMedication for Side Effects180 MinutesNone1 Participants
Intravenous HydromorphoneMedication for Side Effects90 MinutesOndansetron0 Participants
Intravenous HydromorphoneMedication for Side Effects150 MinutesDiphenhydramine0 Participants
Intravenous HydromorphoneMedication for Side Effects90 MinutesMetoclopramide0 Participants
Secondary

Missed Diagnosis

Yes or no, did the patient have a new diagnosis within the next week?

Time frame: 7 days after administration of study drug

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intravenous LidocaineMissed DiagnosisYes0 Participants
Intravenous LidocaineMissed DiagnosisNo3 Participants
Intravenous HydromorphoneMissed DiagnosisYes1 Participants
Intravenous HydromorphoneMissed DiagnosisNo0 Participants
Secondary

Patient Preference for the Medication They Received

If the patient were to come to the ED again for the same complaint, would they want the same study drug they received?

Time frame: Day 7

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intravenous LidocainePatient Preference for the Medication They Received1 Participants
Intravenous HydromorphonePatient Preference for the Medication They Received1 Participants
Secondary

Serious Adverse Event

Yes or no, did the patient suffer a serious adverse event? Defined as death, requiring or prolonging inpatient hospitalization, resulting in persistent or significant disability/incapacity, or is considered a significant medical event by the investigator based off of medical judgement.

Time frame: 180 minutes after administration of study drug

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intravenous LidocaineSerious Adverse EventYes0 Participants
Intravenous LidocaineSerious Adverse EventNo3 Participants
Intravenous HydromorphoneSerious Adverse EventYes0 Participants
Intravenous HydromorphoneSerious Adverse EventNo1 Participants
Secondary

Side Effects

Yes or no, did the patient have any side effects, defined as any new symptom after the administration of the study drug.

Time frame: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes and at 7 days

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Intravenous LidocaineSide Effects60 MinutesNone1 Participants
Intravenous LidocaineSide Effects15 MinutesNausea0 Participants
Intravenous LidocaineSide Effects15 MinutesVomiting0 Participants
Intravenous LidocaineSide Effects15 MinutesDizziness0 Participants
Intravenous LidocaineSide Effects15 MinutesLightheadedness0 Participants
Intravenous LidocaineSide Effects15 MinutesParesthesia0 Participants
Intravenous LidocaineSide Effects15 MinutesWeakness0 Participants
Intravenous LidocaineSide Effects15 MinutesSlurred speech0 Participants
Intravenous LidocaineSide Effects15 MinutesFeeling tired0 Participants
Intravenous LidocaineSide Effects15 MinutesHeadache1 Participants
Intravenous LidocaineSide Effects15 MinutesOther0 Participants
Intravenous LidocaineSide Effects30 MinutesNone2 Participants
Intravenous LidocaineSide Effects30 MinutesNausea0 Participants
Intravenous LidocaineSide Effects30 MinutesVomiting0 Participants
Intravenous LidocaineSide Effects30 MinutesDizziness0 Participants
Intravenous LidocaineSide Effects30 MinutesLightheadedness0 Participants
Intravenous LidocaineSide Effects30 MinutesParesthesia0 Participants
Intravenous LidocaineSide Effects30 MinutesWeakness0 Participants
Intravenous LidocaineSide Effects30 MinutesSlurred speech0 Participants
Intravenous LidocaineSide Effects30 MinutesFeeling tired0 Participants
Intravenous LidocaineSide Effects30 MinutesHeadache1 Participants
Intravenous LidocaineSide Effects30 MinutesOther0 Participants
Intravenous LidocaineSide Effects15 MinutesNone2 Participants
Intravenous LidocaineSide Effects60 MinutesNausea0 Participants
Intravenous LidocaineSide Effects60 MinutesVomiting0 Participants
Intravenous LidocaineSide Effects60 MinutesDizziness0 Participants
Intravenous LidocaineSide Effects60 MinutesLightheadedness0 Participants
Intravenous LidocaineSide Effects60 MinutesParesthesia0 Participants
Intravenous LidocaineSide Effects60 MinutesWeakness0 Participants
Intravenous LidocaineSide Effects60 MinutesSlurred speech0 Participants
Intravenous LidocaineSide Effects60 MinutesFeeling tired1 Participants
Intravenous LidocaineSide Effects60 MinutesHeadache1 Participants
Intravenous LidocaineSide Effects60 MinutesOther0 Participants
Intravenous LidocaineSide Effects90 MinutesNone1 Participants
Intravenous LidocaineSide Effects90 MinutesNausea1 Participants
Intravenous LidocaineSide Effects90 MinutesVomiting0 Participants
Intravenous LidocaineSide Effects90 MinutesDizziness0 Participants
Intravenous LidocaineSide Effects90 MinutesLightheadedness0 Participants
Intravenous LidocaineSide Effects90 MinutesParesthesia1 Participants
Intravenous LidocaineSide Effects90 MinutesWeakness0 Participants
Intravenous LidocaineSide Effects90 MinutesSlurred speech0 Participants
Intravenous LidocaineSide Effects90 MinutesFeeling tired0 Participants
Intravenous LidocaineSide Effects90 MinutesHeadache0 Participants
Intravenous LidocaineSide Effects90 MinutesOther0 Participants
Intravenous LidocaineSide Effects120 MinutesNone3 Participants
Intravenous LidocaineSide Effects120 MinutesNausea0 Participants
Intravenous LidocaineSide Effects120 MinutesVomiting0 Participants
Intravenous LidocaineSide Effects120 MinutesDizziness0 Participants
Intravenous LidocaineSide Effects120 MinutesLightheadedness0 Participants
Intravenous LidocaineSide Effects120 MinutesParesthesia0 Participants
Intravenous LidocaineSide Effects120 MinutesWeakness0 Participants
Intravenous LidocaineSide Effects120 MinutesSlurred speech0 Participants
Intravenous LidocaineSide Effects120 MinutesFeeling tired0 Participants
Intravenous LidocaineSide Effects120 MinutesHeadache0 Participants
Intravenous LidocaineSide Effects120 MinutesOther0 Participants
Intravenous LidocaineSide Effects150 MinutesNone3 Participants
Intravenous LidocaineSide Effects150 MinutesNausea0 Participants
Intravenous LidocaineSide Effects150 MinutesVomiting0 Participants
Intravenous LidocaineSide Effects150 MinutesDizziness0 Participants
Intravenous LidocaineSide Effects150 MinutesLightheadedness0 Participants
Intravenous LidocaineSide Effects150 MinutesParesthesia0 Participants
Intravenous LidocaineSide Effects150 MinutesWeakness0 Participants
Intravenous LidocaineSide Effects150 MinutesSlurred speech0 Participants
Intravenous LidocaineSide Effects150 MinutesFeeling tired0 Participants
Intravenous LidocaineSide Effects150 MinutesHeadache0 Participants
Intravenous LidocaineSide Effects150 MinutesOther0 Participants
Intravenous LidocaineSide Effects180 MinutesNone3 Participants
Intravenous LidocaineSide Effects180 MinutesNausea0 Participants
Intravenous LidocaineSide Effects180 MinutesVomiting0 Participants
Intravenous LidocaineSide Effects180 MinutesDizziness0 Participants
Intravenous LidocaineSide Effects180 MinutesLightheadedness0 Participants
Intravenous LidocaineSide Effects180 MinutesParesthesia0 Participants
Intravenous LidocaineSide Effects180 MinutesWeakness0 Participants
Intravenous LidocaineSide Effects180 MinutesSlurred speech0 Participants
Intravenous LidocaineSide Effects180 MinutesFeeling tired0 Participants
Intravenous LidocaineSide Effects180 MinutesHeadache0 Participants
Intravenous LidocaineSide Effects180 MinutesOther0 Participants
Intravenous LidocaineSide Effects7 DaysNone3 Participants
Intravenous LidocaineSide Effects7 DaysNausea0 Participants
Intravenous LidocaineSide Effects7 DaysVomiting0 Participants
Intravenous LidocaineSide Effects7 DaysDizziness0 Participants
Intravenous LidocaineSide Effects7 DaysLightheadedness0 Participants
Intravenous LidocaineSide Effects7 DaysParesthesia0 Participants
Intravenous LidocaineSide Effects7 DaysWeakness0 Participants
Intravenous LidocaineSide Effects7 DaysSlurred speech0 Participants
Intravenous LidocaineSide Effects7 DaysFeeling tired0 Participants
Intravenous LidocaineSide Effects7 DaysHeadache0 Participants
Intravenous LidocaineSide Effects7 DaysOther0 Participants
Intravenous HydromorphoneSide Effects7 DaysParesthesia0 Participants
Intravenous HydromorphoneSide Effects15 MinutesNone1 Participants
Intravenous HydromorphoneSide Effects120 MinutesNone1 Participants
Intravenous HydromorphoneSide Effects15 MinutesNausea0 Participants
Intravenous HydromorphoneSide Effects180 MinutesNone1 Participants
Intravenous HydromorphoneSide Effects15 MinutesVomiting0 Participants
Intravenous HydromorphoneSide Effects120 MinutesNausea0 Participants
Intravenous HydromorphoneSide Effects15 MinutesDizziness0 Participants
Intravenous HydromorphoneSide Effects7 DaysNone0 Participants
Intravenous HydromorphoneSide Effects15 MinutesLightheadedness0 Participants
Intravenous HydromorphoneSide Effects120 MinutesVomiting0 Participants
Intravenous HydromorphoneSide Effects15 MinutesParesthesia0 Participants
Intravenous HydromorphoneSide Effects180 MinutesNausea0 Participants
Intravenous HydromorphoneSide Effects15 MinutesWeakness0 Participants
Intravenous HydromorphoneSide Effects120 MinutesDizziness0 Participants
Intravenous HydromorphoneSide Effects15 MinutesSlurred speech0 Participants
Intravenous HydromorphoneSide Effects7 DaysFeeling tired0 Participants
Intravenous HydromorphoneSide Effects15 MinutesFeeling tired0 Participants
Intravenous HydromorphoneSide Effects120 MinutesLightheadedness0 Participants
Intravenous HydromorphoneSide Effects15 MinutesHeadache0 Participants
Intravenous HydromorphoneSide Effects180 MinutesVomiting0 Participants
Intravenous HydromorphoneSide Effects15 MinutesOther0 Participants
Intravenous HydromorphoneSide Effects120 MinutesParesthesia0 Participants
Intravenous HydromorphoneSide Effects30 MinutesNone1 Participants
Intravenous HydromorphoneSide Effects7 DaysNausea1 Participants
Intravenous HydromorphoneSide Effects30 MinutesNausea0 Participants
Intravenous HydromorphoneSide Effects120 MinutesWeakness0 Participants
Intravenous HydromorphoneSide Effects30 MinutesVomiting0 Participants
Intravenous HydromorphoneSide Effects180 MinutesDizziness0 Participants
Intravenous HydromorphoneSide Effects30 MinutesDizziness0 Participants
Intravenous HydromorphoneSide Effects120 MinutesSlurred speech0 Participants
Intravenous HydromorphoneSide Effects30 MinutesLightheadedness0 Participants
Intravenous HydromorphoneSide Effects7 DaysWeakness0 Participants
Intravenous HydromorphoneSide Effects30 MinutesParesthesia0 Participants
Intravenous HydromorphoneSide Effects120 MinutesFeeling tired0 Participants
Intravenous HydromorphoneSide Effects30 MinutesWeakness0 Participants
Intravenous HydromorphoneSide Effects180 MinutesLightheadedness0 Participants
Intravenous HydromorphoneSide Effects30 MinutesSlurred speech0 Participants
Intravenous HydromorphoneSide Effects120 MinutesHeadache0 Participants
Intravenous HydromorphoneSide Effects30 MinutesFeeling tired0 Participants
Intravenous HydromorphoneSide Effects7 DaysVomiting0 Participants
Intravenous HydromorphoneSide Effects30 MinutesHeadache0 Participants
Intravenous HydromorphoneSide Effects120 MinutesOther0 Participants
Intravenous HydromorphoneSide Effects30 MinutesOther0 Participants
Intravenous HydromorphoneSide Effects180 MinutesParesthesia0 Participants
Intravenous HydromorphoneSide Effects60 MinutesNone1 Participants
Intravenous HydromorphoneSide Effects150 MinutesNone1 Participants
Intravenous HydromorphoneSide Effects60 MinutesNausea0 Participants
Intravenous HydromorphoneSide Effects7 DaysOther0 Participants
Intravenous HydromorphoneSide Effects60 MinutesVomiting0 Participants
Intravenous HydromorphoneSide Effects150 MinutesNausea0 Participants
Intravenous HydromorphoneSide Effects60 MinutesDizziness0 Participants
Intravenous HydromorphoneSide Effects180 MinutesWeakness0 Participants
Intravenous HydromorphoneSide Effects60 MinutesLightheadedness0 Participants
Intravenous HydromorphoneSide Effects150 MinutesVomiting0 Participants
Intravenous HydromorphoneSide Effects60 MinutesParesthesia0 Participants
Intravenous HydromorphoneSide Effects7 DaysDizziness0 Participants
Intravenous HydromorphoneSide Effects60 MinutesWeakness0 Participants
Intravenous HydromorphoneSide Effects150 MinutesDizziness0 Participants
Intravenous HydromorphoneSide Effects60 MinutesSlurred speech0 Participants
Intravenous HydromorphoneSide Effects180 MinutesSlurred speech0 Participants
Intravenous HydromorphoneSide Effects60 MinutesFeeling tired0 Participants
Intravenous HydromorphoneSide Effects150 MinutesLightheadedness0 Participants
Intravenous HydromorphoneSide Effects60 MinutesHeadache0 Participants
Intravenous HydromorphoneSide Effects7 DaysSlurred speech0 Participants
Intravenous HydromorphoneSide Effects60 MinutesOther0 Participants
Intravenous HydromorphoneSide Effects150 MinutesParesthesia0 Participants
Intravenous HydromorphoneSide Effects90 MinutesNone1 Participants
Intravenous HydromorphoneSide Effects180 MinutesFeeling tired0 Participants
Intravenous HydromorphoneSide Effects90 MinutesNausea0 Participants
Intravenous HydromorphoneSide Effects150 MinutesWeakness0 Participants
Intravenous HydromorphoneSide Effects90 MinutesVomiting0 Participants
Intravenous HydromorphoneSide Effects7 DaysLightheadedness0 Participants
Intravenous HydromorphoneSide Effects90 MinutesDizziness0 Participants
Intravenous HydromorphoneSide Effects150 MinutesSlurred speech0 Participants
Intravenous HydromorphoneSide Effects90 MinutesLightheadedness0 Participants
Intravenous HydromorphoneSide Effects180 MinutesHeadache0 Participants
Intravenous HydromorphoneSide Effects90 MinutesParesthesia0 Participants
Intravenous HydromorphoneSide Effects150 MinutesFeeling tired0 Participants
Intravenous HydromorphoneSide Effects90 MinutesWeakness0 Participants
Intravenous HydromorphoneSide Effects7 DaysHeadache0 Participants
Intravenous HydromorphoneSide Effects90 MinutesSlurred speech0 Participants
Intravenous HydromorphoneSide Effects150 MinutesHeadache0 Participants
Intravenous HydromorphoneSide Effects90 MinutesFeeling tired0 Participants
Intravenous HydromorphoneSide Effects180 MinutesOther0 Participants
Intravenous HydromorphoneSide Effects90 MinutesHeadache0 Participants
Intravenous HydromorphoneSide Effects150 MinutesOther0 Participants
Intravenous HydromorphoneSide Effects90 MinutesOther0 Participants
Secondary

Sufficient Pain Relief

Does the patient require off-protocol medication for additional pain relief? Off-protocol defined as any opiate or NSAID

Time frame: From administration of study drug until patient leaves the emergency department, up until 3 hours from administration of study drug.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intravenous LidocaineSufficient Pain Relief2 Participants
Intravenous HydromorphoneSufficient Pain Relief1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026