Pain
Conditions
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Side Effects | 0 - 60 minutes | The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects | 5, 10, 15, 20, 30, 45, 60 minutes | 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. |
| Side Effect Severity | 5, 10, 15, 20, 30, 45, 60 minutes | 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. |
| How Bothersome Are the Side Effects? | 5, 10, 15, 20, 30, 45, 60 minutes | 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) |
| Reduction in Pain on Numeric Rating Scale. | 5, 10 , 15, 20, 30, 45, 60 minutes | 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). |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | At radiology for 45 & 60 min time points | 0 | 1 |
| Overall Study | Discharged prior to study drug receipt | 0 | 2 |
| Overall Study | Withdrawal before first time point | 1 | 0 |
Baseline characteristics
| Characteristic | Ketamine IV Infusion | Ketamine IV Push | Total |
|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 12 | 46.6 years STANDARD_DEVIATION 15.4 | 43.2 years STANDARD_DEVIATION 14.1 |
| Pain numeric rating scale at time 0 | 8.6 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 Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 0 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine IV Infusion | Side Effects | 21 Participants |
| Ketamine IV Push | Side Effects | 25 Participants |
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Fatigue at 5 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Fatigue at 10 minutes | 0.4 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Fatigue at 15 minutes | 0.3 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Fatigue at 20 minutes | 0.3 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Dizziness at 30 minutes | 0.3 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Fatigue at 30 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Fatigue at 45 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Fatigue at 60 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Dizziness at 5 minutes | 0.5 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Dizziness at 10 minutes | 0.6 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Dizziness at 15 minutes | 0.5 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Dizziness at 20 minutes | 0.5 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Dizziness at 45 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Dizziness at 60 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Headache at 5 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Headache at 10 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hearing at 10 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Headache at 15 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Headache at 20 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Headache at 30 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Headache at 45 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Headache at 60 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hearing at 30 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Unreality at 5 minutes | 0.3 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Unreality at 10 minutes | 0.6 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Unreality at 15 minutes | 0.5 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hearing at 45 minutes | 0 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Unreality at 20 minutes | 0.5 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Unreality at 30 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Unreality at 45 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Unreality at 60 minutes | 0.03 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hearing at 5 minutes | 0 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hearing at 15 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hearing at 20 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hearing at 60 minutes | 0 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Vision at 5 minutes | 0 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Vision at 10 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Vision at 15 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Vision at 20 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Vision at 30 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Vision at 45 minutes | 0 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Vision at 60 minutes | 0 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Mood at 5 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Mood at 10 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Mood at 15 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Mood at 20 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Mood at 30 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Mood at 45 minutes | 0.3 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Mood at 60 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Discomfort at 5 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Discomfort at 10 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Discomfort at 15 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Discomfort at 45 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Discomfort at 20 minutes | 0.03 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Discomfort at 30 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Discomfort at 60 minutes | 0.2 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hallucinations at 5 minutes | 0 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hallucinations at 10 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hallucinations at 15 minutes | 0 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hallucinations at 20 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hallucinations at 30 minutes | 0.1 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hallucinations at 45 minutes | 0 score on a scale |
| Ketamine IV Infusion | How Bothersome Are the Side Effects? | Hallucinations at 60 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hearing at 10 minutes | 0.1 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Fatigue at 5 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Mood at 45 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Fatigue at 10 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hearing at 15 minutes | 0.1 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Fatigue at 15 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Discomfort at 60 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hearing at 20 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Fatigue at 20 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Mood at 60 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Dizziness at 30 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Fatigue at 30 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hearing at 60 minutes | 0.04 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Fatigue at 45 minutes | 0.1 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hallucinations at 20 minutes | 0.1 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Fatigue at 60 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Vision at 5 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Dizziness at 5 minutes | 1.4 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Discomfort at 5 minutes | 0.4 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Dizziness at 10 minutes | 0.9 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Vision at 10 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Dizziness at 15 minutes | 0.7 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hallucinations at 5 minutes | 0.8 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Dizziness at 20 minutes | 0.6 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Vision at 15 minutes | 0.1 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Dizziness at 45 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Discomfort at 10 minutes | 0.4 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Dizziness at 60 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Vision at 20 minutes | 0.1 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Headache at 5 minutes | 0.1 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hallucinations at 45 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Headache at 10 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Vision at 30 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Discomfort at 15 minutes | 0.4 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Headache at 15 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Vision at 45 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Headache at 20 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hallucinations at 10 minutes | 0.5 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Headache at 30 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Vision at 60 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Headache at 45 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hallucinations at 30 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Headache at 60 minutes | 0.2 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Mood at 5 minutes | 0.5 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Discomfort at 20 minutes | 0.4 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Unreality at 5 minutes | 1.6 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Mood at 10 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Unreality at 10 minutes | 0.9 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hallucinations at 15 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Unreality at 15 minutes | 0.4 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hearing at 30 minutes | 0.1 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Mood at 15 minutes | 0.4 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Discomfort at 30 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Unreality at 20 minutes | 0.1 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Mood at 20 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Unreality at 30 minutes | 0.03 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Discomfort at 45 minutes | 0.3 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Unreality at 45 minutes | 0.03 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Mood at 30 minutes | 0.03 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hearing at 45 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Unreality at 60 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hallucinations at 60 minutes | 0 score on a scale |
| Ketamine IV Push | How Bothersome Are the Side Effects? | Hearing at 5 minutes | 0.2 score on a scale |
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ketamine IV Infusion | Reduction in Pain on Numeric Rating Scale. | 45 minutes | 5.3 score on a scale |
| Ketamine IV Infusion | Reduction in Pain on Numeric Rating Scale. | 60 minutes | 5.4 score on a scale |
| Ketamine IV Infusion | Reduction in Pain on Numeric Rating Scale. | 5 minutes | 6.5 score on a scale |
| Ketamine IV Infusion | Reduction in Pain on Numeric Rating Scale. | 10 minutes | 5.4 score on a scale |
| Ketamine IV Infusion | Reduction in Pain on Numeric Rating Scale. | 15 minutes | 4.7 score on a scale |
| Ketamine IV Infusion | Reduction in Pain on Numeric Rating Scale. | 20 minutes | 4.3 score on a scale |
| Ketamine IV Infusion | Reduction in Pain on Numeric Rating Scale. | 30 minutes | 4.8 score on a scale |
| Ketamine IV Push | Reduction in Pain on Numeric Rating Scale. | 60 minutes | 4.5 score on a scale |
| Ketamine IV Push | Reduction in Pain on Numeric Rating Scale. | 45 minutes | 4.6 score on a scale |
| Ketamine IV Push | Reduction in Pain on Numeric Rating Scale. | 15 minutes | 3.4 score on a scale |
| Ketamine IV Push | Reduction in Pain on Numeric Rating Scale. | 30 minutes | 4.2 score on a scale |
| Ketamine IV Push | Reduction in Pain on Numeric Rating Scale. | 5 minutes | 2.9 score on a scale |
| Ketamine IV Push | Reduction in Pain on Numeric Rating Scale. | 20 minutes | 3.9 score on a scale |
| Ketamine IV Push | Reduction in Pain on Numeric Rating Scale. | 10 minutes | 2.8 score on a scale |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ketamine IV Infusion | Side Effects | 15 minutes | 16 participants |
| Ketamine IV Infusion | Side Effects | 30 minutes | 13 participants |
| Ketamine IV Infusion | Side Effects | 10 minutes | 17 participants |
| Ketamine IV Infusion | Side Effects | 45 minutes | 9 participants |
| Ketamine IV Infusion | Side Effects | 20 minutes | 13 participants |
| Ketamine IV Infusion | Side Effects | 60 minutes | 8 participants |
| Ketamine IV Infusion | Side Effects | 5 minutes | 10 participants |
| Ketamine IV Push | Side Effects | 60 minutes | 5 participants |
| Ketamine IV Push | Side Effects | 5 minutes | 20 participants |
| Ketamine IV Push | Side Effects | 10 minutes | 18 participants |
| Ketamine IV Push | Side Effects | 15 minutes | 15 participants |
| Ketamine IV Push | Side Effects | 20 minutes | 12 participants |
| Ketamine IV Push | Side Effects | 30 minutes | 9 participants |
| Ketamine IV Push | Side Effects | 45 minutes | 5 participants |
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ketamine IV Infusion | Side Effect Severity | Fatigue at 5 minutes | 0.4 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hearing at 15 minutes | 0.3 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Headache at 10 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hearing at 20 minutes | 0.4 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Dizziness at 10 minutes | 1.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hearing at 30 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Headache at 15 minutes | 0.3 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hearing at 45 minutes | 0 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Fatigue at 30 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Vision at 10 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Headache at 20 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Vision at 15 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Dizziness at 15 minutes | 1.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Vision at 20 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Headache at 30 minutes | 0.3 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Vision at 30 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Fatigue at 15 minutes | .6 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Vision at 45 minutes | 0 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Headache at 45 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Vision at 60 minutes | 0 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Dizziness at 20 minutes | 1.0 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Mood at 5 minutes | 0.8 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Headache at 60 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Mood at 10 minutes | 1.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Fatigue at 45 minutes | 0.3 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Mood at 15 minutes | 1.4 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Unreality at 5 minutes | 0.9 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Mood at 20 minutes | 1.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Fatigue at 10 minutes | 0.9 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Mood at 30 minutes | 0.9 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Unreality at 10 minutes | 1.5 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Mood at 45 minutes | 0.6 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Dizziness at 30 minutes | 0.4 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Mood at 60 minutes | 0.3 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Unreality at 15 minutes | 1.4 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Discomfort at 5 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Fatigue at 60 minutes | 0.3 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Discomfort at 10 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Unreality at 20 minutes | 1.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Discomfort at 15 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Dizziness at 45 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Discomfort at 20 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Unreality at 30 minutes | 0.5 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Discomfort at 30 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Fatigue at 20 minutes | 0.5 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Discomfort at 45 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Unreality at 45 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Discomfort at 60 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Vision at 5 minutes | 0.03 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hallucinations at 5 minutes | 0.03 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Unreality at 60 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hallucinations at 10 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Dizziness at 60 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hallucinations at 15 minutes | 0.03 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hearing at 5 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hallucinations at 20 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Dizziness at 5 minutes | 0.8 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hallucinations at 30 minutes | 0.1 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hearing at 10 minutes | 0.3 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hallucinations at 45 minutes | 0 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Headache at 5 minutes | 0.2 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hallucinations at 60 minutes | 0 units on a scale |
| Ketamine IV Infusion | Side Effect Severity | Hearing at 60 minutes | 0 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hallucinations at 60 minutes | 0 units on a scale |
| Ketamine IV Push | Side Effect Severity | Fatigue at 5 minutes | 0.6 units on a scale |
| Ketamine IV Push | Side Effect Severity | Fatigue at 10 minutes | 0.7 units on a scale |
| Ketamine IV Push | Side Effect Severity | Fatigue at 15 minutes | 0.7 units on a scale |
| Ketamine IV Push | Side Effect Severity | Fatigue at 20 minutes | 0.4 units on a scale |
| Ketamine IV Push | Side Effect Severity | Fatigue at 30 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Fatigue at 45 minutes | 0.4 units on a scale |
| Ketamine IV Push | Side Effect Severity | Fatigue at 60 minutes | 0.5 units on a scale |
| Ketamine IV Push | Side Effect Severity | Dizziness at 5 minutes | 2.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Dizziness at 10 minutes | 1.9 units on a scale |
| Ketamine IV Push | Side Effect Severity | Dizziness at 15 minutes | 1.1 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hearing at 60 minutes | 0.04 units on a scale |
| Ketamine IV Push | Side Effect Severity | Dizziness at 20 minutes | 0.9 units on a scale |
| Ketamine IV Push | Side Effect Severity | Dizziness at 30 minutes | 0.4 units on a scale |
| Ketamine IV Push | Side Effect Severity | Dizziness at 45 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Dizziness at 60 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Headache at 5 minutes | 0.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Headache at 10 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Headache at 15 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Headache at 20 minutes | 0.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Headache at 30 minutes | 0.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Headache at 45 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Headache at 60 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Unreality at 5 minutes | 2.6 units on a scale |
| Ketamine IV Push | Side Effect Severity | Unreality at 10 minutes | 2.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Unreality at 15 minutes | 1.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Unreality at 20 minutes | 0.8 units on a scale |
| Ketamine IV Push | Side Effect Severity | Unreality at 30 minutes | 0.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Unreality at 45 minutes | 0.1 units on a scale |
| Ketamine IV Push | Side Effect Severity | Unreality at 60 minutes | 0 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hearing at 5 minutes | 0.6 units on a scale |
| Ketamine IV Push | Side Effect Severity | Vision at 5 minutes | 0.7 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hearing at 10 minutes | 0.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hearing at 15 minutes | 0.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hearing at 20 minutes | 0.1 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hearing at 30 minutes | 0.1 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hearing at 45 minutes | 0 units on a scale |
| Ketamine IV Push | Side Effect Severity | Vision at 10 minutes | 0.4 units on a scale |
| Ketamine IV Push | Side Effect Severity | Vision at 15 minutes | 0.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Vision at 20 minutes | 0.1 units on a scale |
| Ketamine IV Push | Side Effect Severity | Vision at 30 minutes | 0.03 units on a scale |
| Ketamine IV Push | Side Effect Severity | Vision at 45 minutes | 0 units on a scale |
| Ketamine IV Push | Side Effect Severity | Vision at 60 minutes | 0 units on a scale |
| Ketamine IV Push | Side Effect Severity | Mood at 5 minutes | 1.7 units on a scale |
| Ketamine IV Push | Side Effect Severity | Mood at 10 minutes | 2.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Mood at 15 minutes | 2.0 units on a scale |
| Ketamine IV Push | Side Effect Severity | Mood at 20 minutes | 1.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Mood at 30 minutes | 0.6 units on a scale |
| Ketamine IV Push | Side Effect Severity | Mood at 45 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Mood at 60 minutes | 0.1 units on a scale |
| Ketamine IV Push | Side Effect Severity | Discomfort at 5 minutes | 0.4 units on a scale |
| Ketamine IV Push | Side Effect Severity | Discomfort at 10 minutes | 0.4 units on a scale |
| Ketamine IV Push | Side Effect Severity | Discomfort at 15 minutes | 1.0 units on a scale |
| Ketamine IV Push | Side Effect Severity | Discomfort at 20 minutes | 0.4 units on a scale |
| Ketamine IV Push | Side Effect Severity | Discomfort at 30 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Discomfort at 45 minutes | 0.2 units on a scale |
| Ketamine IV Push | Side Effect Severity | Discomfort at 60 minutes | 0.3 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hallucinations at 5 minutes | 0.9 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hallucinations at 10 minutes | 0.7 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hallucinations at 15 minutes | 0.4 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hallucinations at 20 minutes | 0.1 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hallucinations at 30 minutes | 0 units on a scale |
| Ketamine IV Push | Side Effect Severity | Hallucinations at 45 minutes | 0 units on a scale |