Phase 4 N=62 Randomized Quadruple-blind Treatment

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

Pain

Bottom Line

View on ClinicalTrials.gov: NCT02916927 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcome: Primary: Side Effects — 21; 25 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ketamine IV Infusion (Drug); Ketamine IV push (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alameda Health System
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Side Effects	10; 20; 17; 18; 16; 15	—
SECONDARY Side Effects	10; 20; 17; 18; 16; 15	—
SECONDARY Side Effect Severity	0.4; 0.6; 0.9; 0.7; .6; 0.7	—
SECONDARY How Bothersome Are the Side Effects?	0.1; 0.2; 0.4; 0.3; 0.3; 0.2	—
SECONDARY Reduction in Pain on Numeric Rating Scale.	6.5; 2.9; 5.4; 2.8; 4.7; 3.4	—

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.

Eligibility Criteria

Inclusion Criteria

Pain NRS ≥5
Anticipated stay in ED ≥1 hour

Exclusion Criteria

Pregnant or breast feeding
Vital sign abnormalities (SBP 180, HR 150, RR 30, 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02916927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.