Abdominal Pain
Conditions
Brief summary
This is a randomized, double-blind, emergency department based, comparative effectiveness study of two medication for acute abdominal pain: intravenous lidocaine and intravenous hydromorphone. Patients will be enrolled during an emergency department visit and followed throughout their emergency department course and then by telephone 7 days later.
Interventions
DRUGHydromorphone
Hydromorphone intravenous infusion
DRUGLidocaine
Lidocaine intravenous infusion
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible patients are those who present to an ED for treatment of acute abdominal pain. Acute will be defined as pain for no more than seven days. At the time of enrollment, the ED treatment plan must include use of an intravenous opioid.
Exclusion criteria
Patients will be excluded from participation if they have cardiac conduction system impairment (QTc duration \> 0.5s, QRS duration \> 0.12s, or PR interval duration \> 0.2s), known renal (CKD \>2) or liver disease (Childs-Pugh B or greater), are hemodynamically unstable, as determined by the attending physician, are pregnant or breastfeeding, or have a known allergy to either medication. Patients will also be excluded if they have used prescription or illicit opioids within the previous week, or if they have a chronic pain disorder, defined as use of any analgesic medication on more days than not during the month preceding the acute episode of pain. Patients weighing \< 60kg or \> 120kg will be excluded. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 0-10 Pain Scale Between Baseline and 90 Minutes | up to 90 minutes | Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Medication | 4 hours | no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug |
| Adverse Events | 4 hours | Any new symptom development after administration of investigational medication |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Hydromorphone Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.
Hydromorphone: Hydromorphone intravenous infusion | 77 |
| Intravenous Lidocaine Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes
Lidocaine: Lidocaine intravenous infusion | 77 |
| Total | 154 |
Baseline characteristics
| Characteristic | Intravenous Hydromorphone | Intravenous Lidocaine | Total |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 13 | 42 years STANDARD_DEVIATION 12 | 41 years STANDARD_DEVIATION 13 |
| Pain duration in days | 2 days | 2 days | 2 days |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 77 participants | 77 participants | 154 participants |
| Sex: Female, Male Female | 44 Participants | 54 Participants | 98 Participants |
| Sex: Female, Male Male | 33 Participants | 23 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 77 |
| other Total, other adverse events | 28 / 77 | 23 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
Primary
Change in 0-10 Pain Scale Between Baseline and 90 Minutes
Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Hydromorphone | Change in 0-10 Pain Scale Between Baseline and 90 Minutes | 5.0 units on a scale | Standard Deviation 2.8 |
| Intravenous Lidocaine | Change in 0-10 Pain Scale Between Baseline and 90 Minutes | 3.8 units on a scale | Standard Deviation 2.2 |
Secondary
Adverse Events
Any new symptom development after administration of investigational medication
Time frame: 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Hydromorphone | Adverse Events | 28 Participants |
| Intravenous Lidocaine | Adverse Events | 23 Participants |
Secondary
Rescue Medication
no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug
Time frame: 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Hydromorphone | Rescue Medication | 20 Participants |
| Intravenous Lidocaine | Rescue Medication | 39 Participants |