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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine IV infusion | Experimental | 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 push | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine IV Infusion | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects | The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes. | 0 - 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5, 10, 15, 20, 30, 45, 60 minutes |
| Side Effect Severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alameda Health System, Highland Hospital | Oakland | California | 94602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29645317 | Derived | Clattenburg EJ, Hailozian C, Haro D, Yoo T, Flores S, Louie D, Herring AA. Slow Infusion of Low-dose Ketamine Reduces Bothersome Side Effects Compared to Intravenous Push: A Double-blind, Double-dummy, Randomized Controlled Trial. Acad Emerg Med. 2018 Sep;25(9):1048-1052. doi: 10.1111/acem.13428. Epub 2018 May 25. |
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62 rather than 56 patients were enrolled because we were concerned about participants not completing the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Side Effects | The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes. | There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point. | Posted | Count of Participants | Participants | 0 - 60 minutes |
|
Adverse events were collected over the 60 minute study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Herring | Alameda Health Systemt - Highland Hospital | (510) 437-4564 | aherring@alamedahealthsystem.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2015 | Mar 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine IV push | Drug | 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. |
|
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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.
| 5, 10, 15, 20, 30, 45, 60 minutes |
| 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) | 5, 10, 15, 20, 30, 45, 60 minutes |
| 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). | 5, 10 , 15, 20, 30, 45, 60 minutes |
| Withdrawal before first time point |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Pain numeric rating scale at time 0 | Pain numeric rating scale (NRS) from 0 (no pain) to 10 (maximal pain). | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| 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. |
|
|
| 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. | 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. | Posted | Number | participants | 5, 10, 15, 20, 30, 45, 60 minutes |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 5, 10, 15, 20, 30, 45, 60 minutes |
|
|
|
| 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) | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 5, 10, 15, 20, 30, 45, 60 minutes |
|
|
|
| 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). | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 5, 10 , 15, 20, 30, 45, 60 minutes |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D010335 | Pathologic Processes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
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