Clinical trial NCT02916927: Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department
Official title: Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department: A Prospective, Randomized, Double-blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: ketamine
emergency department
Lead sponsor: Alameda Health System
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Side Effects
timeFrame: 0 - 60 minutes
Secondary outcomes:
measure: Side Effects
timeFrame: 5, 10, 15, 20, 30, 45, 60 minutes
measure: Side Effect Severity
timeFrame: 5, 10, 15, 20, 30, 45, 60 minutes
measure: How Bothersome Are the Side Effects?
timeFrame: 5, 10, 15, 20, 30, 45, 60 minutes
measure: Reduction in Pain on Numeric Rating Scale.
timeFrame: 5, 10 , 15, 20, 30, 45, 60 minutes
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Alameda Health System, Highland Hospital
state: California
Study officials:
References:
citation: 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.