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Low-dose Ketamine vs Morphine for Vaso-occlusive Crisis in Sicklers

NCT02434939 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-08-03

Study results available
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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.

Conditions

  • Sickle Cell Crisis
  • Acute Pain

Interventions

DRUG

Low dose ketamine

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.

DRUG

Morphine

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.

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • Felix A. Lubega, MBChB · Makerere University, College of Health Sciences, Department of Anesthesia and Critical Care

  • Tonny S. Luggya, MMed · Makerere University, College of Health Sciences, Department of Anaesthesia and Critical care

  • Deogratias Munube, MMed · Makerere University, College of Health Sciences, Department of Child Health and Pediatrics

  • Fred Bulamba, MBChB · Makerere University, College of Health Sciences, Department of Anaesthesia and Critical care

  • Mithrika S De Silva, MD · University of Sydney, Department of Peadiatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-01-31
Completion
2016-02-29

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02434939 on ClinicalTrials.gov