The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes.
Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the 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.
Intervention / Treatment
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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.
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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.
Condition or Disease
- Pain
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 62 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Sep 01, 2016 | |
|---|---|---|
| Primary Completion: | Apr 01, 2017 | ACTUAL |
| Completion Date: | Apr 01, 2017 | ACTUAL |
| Study First Posted: | Sep 28, 2016 | ESTIMATED |
| Results First Posted: | Apr 17, 2020 | ACTUAL |
| Last Updated: | Apr 04, 2020 |
Sponsors / Collaborators
Lead Sponsor:
Alameda Health System
Responsible Party:
N/A
Location
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.
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.
Participant Groups
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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.
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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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
Secondary Outcomes
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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.
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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.
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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)
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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).
More Details
| NCT Number: | NCT02916927 |
|---|---|
| Other IDs: | 00002 |
| Study URL: | https://clinicaltrials.gov/study/NCT02916927 |
Last updated: Sep 29, 2023