CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 183 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 1.0 milligramsfrom 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/NCT01387139
NCT01387139Phase 3Completed

Comparison of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

University of Colorado, Denver·interventional·Posted Jul 4, 2011·Updated Dec 8, 2017

In Brief

A Phase 3 clinical trial evaluating Ketamine and Ketamine Co-administered with Propofol for Procedural Sedation and Analgesia. Completed, enrolled 183 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the effectiveness of the co-administration of intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural sedation in the pediatric emergency department. The investigators hypothesize that patients receiving co-administration of ketamine and propofol will have a lower rate of adverse events, compared to patients receiving ketamine for procedural sedation.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 4, 2011
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2014
Study CompletionNov 3, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.0 years ago

Interventions

Ketaminedrug

1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)

Ketamine Co-administered with Propofoldrug

0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)