CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Ketamine 0.75 mg/kg +2 moredrug
Likely dose
Ketamine 0.75 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03909607
NCT03909607Phase 4Completed

Comparison of Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute and Chronic Painful Conditions in the ED: A Prospective, Randomized Trial

Antonios Likourezos·interventional·Posted Apr 10, 2019·Updated Jun 15, 2022

In Brief

A Phase 4 clinical trial evaluating Ketamine 0.75 mg/kg, Ketamine 1.0 mg/kg, and 1 other intervention for Pain. Completed, enrolled 120 participants across 1 site.

Detailed Summary

The investigators previous research study comparing the efficacy of intravenous ketamine to morphine showed ketamine to provide equivalent relief of moderate to severe acute pain in emergency department patients. A second study by the investigators showed that increasing the time of administration of the ketamine, from a push injection to a drip infusion, will minimize the adverse effects experienced by recipients of ketamine. The investigators now aim to see if nebulized subdissociative-dose ketamine administered as a single agent in a dose of 1.5 mg/kg via Breath-Actuated Nebulizers (BAN) over 5-15 minutes will provide a better pain relief in comparison to 1 mg/kg and 0.75 mg/kg doses or if the lower doses are equally as effective.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 10, 2019
Enrollment StartApr 16, 2019
Primary CompletionOct 30, 2020
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.2 years ago

Interventions

Ketamine 0.75 mg/kgdrug

Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg

Ketamine 1.0 mg/kgdrug

Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg

Ketamine 1.5 mg/kgdrug

Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg