CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 240 enrolled
Drug / intervention
Low dose ketamine +1 moredrug
Likely dose
Not stated in 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/NCT02434939
NCT02434939Phase 4Completed

Low-dose Ketamine Versus Morphine for Severe Painful Sickle Cell Crises in Children at Mulago Hospital: A Randomised Controlled Trial

Makerere University·interventional·Posted May 6, 2015·Updated Aug 3, 2016

In Brief

A Phase 4 clinical trial evaluating Low dose ketamine and Morphine for Sickle Cell Crisis and Acute Pain. Completed, enrolled 240 participants across 1 site.

Detailed Summary

This clinical trial will inform of the role of Low dose ketamine in the acute treatment of severe painful sickle cell crisis in children in a day-case sickle cell centre. The primary aim is to determine whether Low dose ketamine is non inferior to morphine in the management of acute painful sickle cell crises. The specific objectives will be to determine the maximal change in NRS pain score following administration of ketamine and to examine the safety profile of ketamine compared to morphine in this population. The investigators hypothesize that low dose ketamine will result in similar effective pain control as morphine alone and will not be associated with an increase in adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUganda
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 6, 2015
Enrollment StartJun 1, 2015
Primary CompletionJan 1, 2016
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.2 years ago

Interventions

Low dose ketaminedrug

Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min.

Morphinedrug

Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min.