Skip to content

Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department

Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department: A Prospective, Randomized, Double-blind Placebo Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02916927
Enrollment
62
Registered
2016-09-28
Start date
2016-09-30
Completion date
2017-04-30
Last updated
2020-04-17

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

Conditions

Pain

Keywords

ketamine, emergency department

Brief summary

Objective: The purpose of this study is to determine if administering ketamine as an intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse drug reactions without attenuating its analgesic effects. Study design: prospective, randomized, controlled, double-blind trial.

Detailed description

Objective: The purpose of this randomized, controlled, double-blind trial is to evaluate if sub-dissociated dose ketamine given as an infusion versus an intravenous (IV) push over 1 minute has fewer and/or less severe adverse drug reactions and provides equivalent analgesia for patients with moderate to severe pain in the emergency department (ED). Study design: Prospective, randomized, controlled, double-blind trial Participants: Research assistants will recruit patients ≥18 years old with moderate to severe pain (NRS≥5) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed based on prior data which suggests that 60% of IV push arm and 20 % of infusion arm will have adverse drug reactions. investigators assume an alpha of 0.05 and a power of 0.8, which results in 56 patients needing to be enrolled. Intervention: After a trained research assistant obtains written informed consent, pharmacists will randomize the participants to the IV push or IV infusion arm of the study. All patients will be placed on a cardiac monitor. All patients will receive and IV push over 1 minute and a 100 mL normal saline minibag over 15 minutes. In the IV push arm, pharmacists will provide to the nurse ketamine 0.3 mg/kg in a 10 mL syringe and a 100 mL normal saline minibag. The nurse will start the minibag of normal saline and then administer the IV push of ketamine over 1 minute. In the IV infusion arm, pharmacists will provide to the nurse ketamine 0.3 mg/kg in a 100 mL normal saline minibag and a 10 mL syringe of normal saline. The nurse will start the minibag of normal saline and then administer the IV push over 1 minute. Data collection: The trained research assistant will collect data on the patients' pain scores, adverse drug reactions (presence, severity, and how bothersome they are), and vital signs. Statistical analysis: Investigators will perform descriptive statistics, compare the proportion of patients with side effects, compare the severity of the side effects scores, and compare how bothersome the side effects.

Interventions

Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.

DRUGKetamine IV push

Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.

Sponsors

Alameda Health System
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 No maximum
Healthy volunteers
No

Inclusion criteria

* Pain NRS ≥5 * Anticipated stay in ED ≥1 hour

Exclusion criteria

* Pregnant or breast feeding * Vital sign abnormalities (SBP \<90, SBP \> 180, HR \< 50, HR \> 150, RR \<10, RR \> 30, weight \<45 kg, weight \> 115 kg) * Arrhythmias * Altered mental status (active psychosis/delirium) * Administration of opioid pain medication in previous 1 hour * history of acute head or ocular trauma * presence of known intracranial mass or vascular lesion

Design outcomes

Primary

MeasureTime frameDescription
Side Effects0 - 60 minutesThe difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes.

Secondary

MeasureTime frameDescription
Side Effects5, 10, 15, 20, 30, 45, 60 minutesThe difference in percentage of participants endorsing side effects between each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.
Side Effect Severity5, 10, 15, 20, 30, 45, 60 minutesThe difference in severity of side effects (0 - 4) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes. 0 indicates no side effects and 4 most severe side effects.
How Bothersome Are the Side Effects?5, 10, 15, 20, 30, 45, 60 minutesThe difference in how bothersome (0, not bothersome, to 4, very bothersome, on the Side Effect Rating Scale for Dissociative Anesthetics SERSDA) the side effects experienced by participants in each arm of the study are at 5, 10, 15, 20, 30, 45, and 60 minutes. 0 (no side effects), 1 (weak), 2 (moderate), 3 (bothersome) to 4 (very bothersome)
Reduction in Pain on Numeric Rating Scale.5, 10 , 15, 20, 30, 45, 60 minutesThe difference in pain numeric rating score (NRS 0-10) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes. Pain numeric rating scale from 0 (no pain) to 10 (maximal pain).

Countries

United States

Participant flow

Pre-assignment details

62 rather than 56 patients were enrolled because we were concerned about participants not completing the study.

Participants by arm

ArmCount
Ketamine IV Infusion
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine. Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
31
Ketamine IV Push
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine. Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
29
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAt radiology for 45 & 60 min time points01
Overall StudyDischarged prior to study drug receipt02
Overall StudyWithdrawal before first time point10

Baseline characteristics

CharacteristicKetamine IV InfusionKetamine IV PushTotal
Age, Continuous39.9 years
STANDARD_DEVIATION 12
46.6 years
STANDARD_DEVIATION 15.4
43.2 years
STANDARD_DEVIATION 14.1
Pain numeric rating scale at time 08.6 units on a scale
STANDARD_DEVIATION 1.6
8.0 units on a scale
STANDARD_DEVIATION 1.4
8.3 units on a scale
STANDARD_DEVIATION 1.5
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
18 Participants20 Participants38 Participants
Sex: Female, Male
Male
13 Participants9 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 29
other
Total, other adverse events
0 / 310 / 29
serious
Total, serious adverse events
0 / 310 / 29

Outcome results

Primary

Side Effects

The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes.

Time frame: 0 - 60 minutes

Population: There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketamine IV InfusionSide Effects21 Participants
Ketamine IV PushSide Effects25 Participants
Secondary

How Bothersome Are the Side Effects?

The difference in how bothersome (0, not bothersome, to 4, very bothersome, on the Side Effect Rating Scale for Dissociative Anesthetics SERSDA) the side effects experienced by participants in each arm of the study are at 5, 10, 15, 20, 30, 45, and 60 minutes. 0 (no side effects), 1 (weak), 2 (moderate), 3 (bothersome) to 4 (very bothersome)

Time frame: 5, 10, 15, 20, 30, 45, 60 minutes

Population: One patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points.~There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.

ArmMeasureGroupValue (MEAN)
Ketamine IV InfusionHow Bothersome Are the Side Effects?Fatigue at 5 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Fatigue at 10 minutes0.4 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Fatigue at 15 minutes0.3 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Fatigue at 20 minutes0.3 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Dizziness at 30 minutes0.3 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Fatigue at 30 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Fatigue at 45 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Fatigue at 60 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Dizziness at 5 minutes0.5 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Dizziness at 10 minutes0.6 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Dizziness at 15 minutes0.5 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Dizziness at 20 minutes0.5 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Dizziness at 45 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Dizziness at 60 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Headache at 5 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Headache at 10 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hearing at 10 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Headache at 15 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Headache at 20 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Headache at 30 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Headache at 45 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Headache at 60 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hearing at 30 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Unreality at 5 minutes0.3 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Unreality at 10 minutes0.6 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Unreality at 15 minutes0.5 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hearing at 45 minutes0 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Unreality at 20 minutes0.5 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Unreality at 30 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Unreality at 45 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Unreality at 60 minutes0.03 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hearing at 5 minutes0 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hearing at 15 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hearing at 20 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hearing at 60 minutes0 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Vision at 5 minutes0 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Vision at 10 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Vision at 15 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Vision at 20 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Vision at 30 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Vision at 45 minutes0 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Vision at 60 minutes0 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Mood at 5 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Mood at 10 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Mood at 15 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Mood at 20 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Mood at 30 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Mood at 45 minutes0.3 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Mood at 60 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Discomfort at 5 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Discomfort at 10 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Discomfort at 15 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Discomfort at 45 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Discomfort at 20 minutes0.03 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Discomfort at 30 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Discomfort at 60 minutes0.2 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hallucinations at 5 minutes0 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hallucinations at 10 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hallucinations at 15 minutes0 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hallucinations at 20 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hallucinations at 30 minutes0.1 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hallucinations at 45 minutes0 score on a scale
Ketamine IV InfusionHow Bothersome Are the Side Effects?Hallucinations at 60 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hearing at 10 minutes0.1 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Fatigue at 5 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Mood at 45 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Fatigue at 10 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hearing at 15 minutes0.1 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Fatigue at 15 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Discomfort at 60 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hearing at 20 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Fatigue at 20 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Mood at 60 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Dizziness at 30 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Fatigue at 30 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hearing at 60 minutes0.04 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Fatigue at 45 minutes0.1 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hallucinations at 20 minutes0.1 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Fatigue at 60 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Vision at 5 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Dizziness at 5 minutes1.4 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Discomfort at 5 minutes0.4 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Dizziness at 10 minutes0.9 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Vision at 10 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Dizziness at 15 minutes0.7 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hallucinations at 5 minutes0.8 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Dizziness at 20 minutes0.6 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Vision at 15 minutes0.1 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Dizziness at 45 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Discomfort at 10 minutes0.4 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Dizziness at 60 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Vision at 20 minutes0.1 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Headache at 5 minutes0.1 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hallucinations at 45 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Headache at 10 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Vision at 30 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Discomfort at 15 minutes0.4 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Headache at 15 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Vision at 45 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Headache at 20 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hallucinations at 10 minutes0.5 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Headache at 30 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Vision at 60 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Headache at 45 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hallucinations at 30 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Headache at 60 minutes0.2 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Mood at 5 minutes0.5 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Discomfort at 20 minutes0.4 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Unreality at 5 minutes1.6 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Mood at 10 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Unreality at 10 minutes0.9 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hallucinations at 15 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Unreality at 15 minutes0.4 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hearing at 30 minutes0.1 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Mood at 15 minutes0.4 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Discomfort at 30 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Unreality at 20 minutes0.1 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Mood at 20 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Unreality at 30 minutes0.03 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Discomfort at 45 minutes0.3 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Unreality at 45 minutes0.03 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Mood at 30 minutes0.03 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hearing at 45 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Unreality at 60 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hallucinations at 60 minutes0 score on a scale
Ketamine IV PushHow Bothersome Are the Side Effects?Hearing at 5 minutes0.2 score on a scale
Secondary

Reduction in Pain on Numeric Rating Scale.

The difference in pain numeric rating score (NRS 0-10) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes. Pain numeric rating scale from 0 (no pain) to 10 (maximal pain).

Time frame: 5, 10 , 15, 20, 30, 45, 60 minutes

Population: One patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points.~There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.

ArmMeasureGroupValue (MEAN)
Ketamine IV InfusionReduction in Pain on Numeric Rating Scale.45 minutes5.3 score on a scale
Ketamine IV InfusionReduction in Pain on Numeric Rating Scale.60 minutes5.4 score on a scale
Ketamine IV InfusionReduction in Pain on Numeric Rating Scale.5 minutes6.5 score on a scale
Ketamine IV InfusionReduction in Pain on Numeric Rating Scale.10 minutes5.4 score on a scale
Ketamine IV InfusionReduction in Pain on Numeric Rating Scale.15 minutes4.7 score on a scale
Ketamine IV InfusionReduction in Pain on Numeric Rating Scale.20 minutes4.3 score on a scale
Ketamine IV InfusionReduction in Pain on Numeric Rating Scale.30 minutes4.8 score on a scale
Ketamine IV PushReduction in Pain on Numeric Rating Scale.60 minutes4.5 score on a scale
Ketamine IV PushReduction in Pain on Numeric Rating Scale.45 minutes4.6 score on a scale
Ketamine IV PushReduction in Pain on Numeric Rating Scale.15 minutes3.4 score on a scale
Ketamine IV PushReduction in Pain on Numeric Rating Scale.30 minutes4.2 score on a scale
Ketamine IV PushReduction in Pain on Numeric Rating Scale.5 minutes2.9 score on a scale
Ketamine IV PushReduction in Pain on Numeric Rating Scale.20 minutes3.9 score on a scale
Ketamine IV PushReduction in Pain on Numeric Rating Scale.10 minutes2.8 score on a scale
Secondary

Side Effects

The difference in percentage of participants endorsing side effects between each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.

Time frame: 5, 10, 15, 20, 30, 45, 60 minutes

Population: 1 patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points.~There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.

ArmMeasureGroupValue (NUMBER)
Ketamine IV InfusionSide Effects15 minutes16 participants
Ketamine IV InfusionSide Effects30 minutes13 participants
Ketamine IV InfusionSide Effects10 minutes17 participants
Ketamine IV InfusionSide Effects45 minutes9 participants
Ketamine IV InfusionSide Effects20 minutes13 participants
Ketamine IV InfusionSide Effects60 minutes8 participants
Ketamine IV InfusionSide Effects5 minutes10 participants
Ketamine IV PushSide Effects60 minutes5 participants
Ketamine IV PushSide Effects5 minutes20 participants
Ketamine IV PushSide Effects10 minutes18 participants
Ketamine IV PushSide Effects15 minutes15 participants
Ketamine IV PushSide Effects20 minutes12 participants
Ketamine IV PushSide Effects30 minutes9 participants
Ketamine IV PushSide Effects45 minutes5 participants
Secondary

Side Effect Severity

The difference in severity of side effects (0 - 4) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes. 0 indicates no side effects and 4 most severe side effects.

Time frame: 5, 10, 15, 20, 30, 45, 60 minutes

Population: One patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points.~There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.

ArmMeasureGroupValue (MEAN)
Ketamine IV InfusionSide Effect SeverityFatigue at 5 minutes0.4 units on a scale
Ketamine IV InfusionSide Effect SeverityHearing at 15 minutes0.3 units on a scale
Ketamine IV InfusionSide Effect SeverityHeadache at 10 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityHearing at 20 minutes0.4 units on a scale
Ketamine IV InfusionSide Effect SeverityDizziness at 10 minutes1.1 units on a scale
Ketamine IV InfusionSide Effect SeverityHearing at 30 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityHeadache at 15 minutes0.3 units on a scale
Ketamine IV InfusionSide Effect SeverityHearing at 45 minutes0 units on a scale
Ketamine IV InfusionSide Effect SeverityFatigue at 30 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityVision at 10 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityHeadache at 20 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityVision at 15 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityDizziness at 15 minutes1.1 units on a scale
Ketamine IV InfusionSide Effect SeverityVision at 20 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityHeadache at 30 minutes0.3 units on a scale
Ketamine IV InfusionSide Effect SeverityVision at 30 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityFatigue at 15 minutes.6 units on a scale
Ketamine IV InfusionSide Effect SeverityVision at 45 minutes0 units on a scale
Ketamine IV InfusionSide Effect SeverityHeadache at 45 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityVision at 60 minutes0 units on a scale
Ketamine IV InfusionSide Effect SeverityDizziness at 20 minutes1.0 units on a scale
Ketamine IV InfusionSide Effect SeverityMood at 5 minutes0.8 units on a scale
Ketamine IV InfusionSide Effect SeverityHeadache at 60 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityMood at 10 minutes1.2 units on a scale
Ketamine IV InfusionSide Effect SeverityFatigue at 45 minutes0.3 units on a scale
Ketamine IV InfusionSide Effect SeverityMood at 15 minutes1.4 units on a scale
Ketamine IV InfusionSide Effect SeverityUnreality at 5 minutes0.9 units on a scale
Ketamine IV InfusionSide Effect SeverityMood at 20 minutes1.2 units on a scale
Ketamine IV InfusionSide Effect SeverityFatigue at 10 minutes0.9 units on a scale
Ketamine IV InfusionSide Effect SeverityMood at 30 minutes0.9 units on a scale
Ketamine IV InfusionSide Effect SeverityUnreality at 10 minutes1.5 units on a scale
Ketamine IV InfusionSide Effect SeverityMood at 45 minutes0.6 units on a scale
Ketamine IV InfusionSide Effect SeverityDizziness at 30 minutes0.4 units on a scale
Ketamine IV InfusionSide Effect SeverityMood at 60 minutes0.3 units on a scale
Ketamine IV InfusionSide Effect SeverityUnreality at 15 minutes1.4 units on a scale
Ketamine IV InfusionSide Effect SeverityDiscomfort at 5 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityFatigue at 60 minutes0.3 units on a scale
Ketamine IV InfusionSide Effect SeverityDiscomfort at 10 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityUnreality at 20 minutes1.1 units on a scale
Ketamine IV InfusionSide Effect SeverityDiscomfort at 15 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityDizziness at 45 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityDiscomfort at 20 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityUnreality at 30 minutes0.5 units on a scale
Ketamine IV InfusionSide Effect SeverityDiscomfort at 30 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityFatigue at 20 minutes0.5 units on a scale
Ketamine IV InfusionSide Effect SeverityDiscomfort at 45 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityUnreality at 45 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityDiscomfort at 60 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityVision at 5 minutes0.03 units on a scale
Ketamine IV InfusionSide Effect SeverityHallucinations at 5 minutes0.03 units on a scale
Ketamine IV InfusionSide Effect SeverityUnreality at 60 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityHallucinations at 10 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityDizziness at 60 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityHallucinations at 15 minutes0.03 units on a scale
Ketamine IV InfusionSide Effect SeverityHearing at 5 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityHallucinations at 20 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityDizziness at 5 minutes0.8 units on a scale
Ketamine IV InfusionSide Effect SeverityHallucinations at 30 minutes0.1 units on a scale
Ketamine IV InfusionSide Effect SeverityHearing at 10 minutes0.3 units on a scale
Ketamine IV InfusionSide Effect SeverityHallucinations at 45 minutes0 units on a scale
Ketamine IV InfusionSide Effect SeverityHeadache at 5 minutes0.2 units on a scale
Ketamine IV InfusionSide Effect SeverityHallucinations at 60 minutes0 units on a scale
Ketamine IV InfusionSide Effect SeverityHearing at 60 minutes0 units on a scale
Ketamine IV PushSide Effect SeverityHallucinations at 60 minutes0 units on a scale
Ketamine IV PushSide Effect SeverityFatigue at 5 minutes0.6 units on a scale
Ketamine IV PushSide Effect SeverityFatigue at 10 minutes0.7 units on a scale
Ketamine IV PushSide Effect SeverityFatigue at 15 minutes0.7 units on a scale
Ketamine IV PushSide Effect SeverityFatigue at 20 minutes0.4 units on a scale
Ketamine IV PushSide Effect SeverityFatigue at 30 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityFatigue at 45 minutes0.4 units on a scale
Ketamine IV PushSide Effect SeverityFatigue at 60 minutes0.5 units on a scale
Ketamine IV PushSide Effect SeverityDizziness at 5 minutes2.2 units on a scale
Ketamine IV PushSide Effect SeverityDizziness at 10 minutes1.9 units on a scale
Ketamine IV PushSide Effect SeverityDizziness at 15 minutes1.1 units on a scale
Ketamine IV PushSide Effect SeverityHearing at 60 minutes0.04 units on a scale
Ketamine IV PushSide Effect SeverityDizziness at 20 minutes0.9 units on a scale
Ketamine IV PushSide Effect SeverityDizziness at 30 minutes0.4 units on a scale
Ketamine IV PushSide Effect SeverityDizziness at 45 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityDizziness at 60 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityHeadache at 5 minutes0.2 units on a scale
Ketamine IV PushSide Effect SeverityHeadache at 10 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityHeadache at 15 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityHeadache at 20 minutes0.2 units on a scale
Ketamine IV PushSide Effect SeverityHeadache at 30 minutes0.2 units on a scale
Ketamine IV PushSide Effect SeverityHeadache at 45 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityHeadache at 60 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityUnreality at 5 minutes2.6 units on a scale
Ketamine IV PushSide Effect SeverityUnreality at 10 minutes2.2 units on a scale
Ketamine IV PushSide Effect SeverityUnreality at 15 minutes1.3 units on a scale
Ketamine IV PushSide Effect SeverityUnreality at 20 minutes0.8 units on a scale
Ketamine IV PushSide Effect SeverityUnreality at 30 minutes0.2 units on a scale
Ketamine IV PushSide Effect SeverityUnreality at 45 minutes0.1 units on a scale
Ketamine IV PushSide Effect SeverityUnreality at 60 minutes0 units on a scale
Ketamine IV PushSide Effect SeverityHearing at 5 minutes0.6 units on a scale
Ketamine IV PushSide Effect SeverityVision at 5 minutes0.7 units on a scale
Ketamine IV PushSide Effect SeverityHearing at 10 minutes0.2 units on a scale
Ketamine IV PushSide Effect SeverityHearing at 15 minutes0.2 units on a scale
Ketamine IV PushSide Effect SeverityHearing at 20 minutes0.1 units on a scale
Ketamine IV PushSide Effect SeverityHearing at 30 minutes0.1 units on a scale
Ketamine IV PushSide Effect SeverityHearing at 45 minutes0 units on a scale
Ketamine IV PushSide Effect SeverityVision at 10 minutes0.4 units on a scale
Ketamine IV PushSide Effect SeverityVision at 15 minutes0.2 units on a scale
Ketamine IV PushSide Effect SeverityVision at 20 minutes0.1 units on a scale
Ketamine IV PushSide Effect SeverityVision at 30 minutes0.03 units on a scale
Ketamine IV PushSide Effect SeverityVision at 45 minutes0 units on a scale
Ketamine IV PushSide Effect SeverityVision at 60 minutes0 units on a scale
Ketamine IV PushSide Effect SeverityMood at 5 minutes1.7 units on a scale
Ketamine IV PushSide Effect SeverityMood at 10 minutes2.3 units on a scale
Ketamine IV PushSide Effect SeverityMood at 15 minutes2.0 units on a scale
Ketamine IV PushSide Effect SeverityMood at 20 minutes1.2 units on a scale
Ketamine IV PushSide Effect SeverityMood at 30 minutes0.6 units on a scale
Ketamine IV PushSide Effect SeverityMood at 45 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityMood at 60 minutes0.1 units on a scale
Ketamine IV PushSide Effect SeverityDiscomfort at 5 minutes0.4 units on a scale
Ketamine IV PushSide Effect SeverityDiscomfort at 10 minutes0.4 units on a scale
Ketamine IV PushSide Effect SeverityDiscomfort at 15 minutes1.0 units on a scale
Ketamine IV PushSide Effect SeverityDiscomfort at 20 minutes0.4 units on a scale
Ketamine IV PushSide Effect SeverityDiscomfort at 30 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityDiscomfort at 45 minutes0.2 units on a scale
Ketamine IV PushSide Effect SeverityDiscomfort at 60 minutes0.3 units on a scale
Ketamine IV PushSide Effect SeverityHallucinations at 5 minutes0.9 units on a scale
Ketamine IV PushSide Effect SeverityHallucinations at 10 minutes0.7 units on a scale
Ketamine IV PushSide Effect SeverityHallucinations at 15 minutes0.4 units on a scale
Ketamine IV PushSide Effect SeverityHallucinations at 20 minutes0.1 units on a scale
Ketamine IV PushSide Effect SeverityHallucinations at 30 minutes0 units on a scale
Ketamine IV PushSide Effect SeverityHallucinations at 45 minutes0 units on a scale

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