Phase 4
N=240
Low-dose Ketamine vs Morphine for Vaso-occlusive Crisis in Sicklers
Sickle Cell Crisis · Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT02434939 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Maximal Change in NRS Pain Scores as a Percentage of Baseline NRS Pain Score. — -66.4; -61.3; -81.1; -79.8 percent change from baseline NRS score. — p=0.18
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Low dose ketamine (Drug); Morphine (Drug)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Makerere University
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Change in NRS Pain Scores as a Percentage of Baseline NRS Pain Score. |
-66.4; -61.3; -81.1; -79.8; -33.8; -33.9 | 0.18 |
| SECONDARY Time to Maximal Analgesic Effect and Duration of Action of Ketamine |
19.8; 34.1; 60; 58.5 | — |
| SECONDARY Incidence of Side Effects, Including Outlying Vital Signs |
45; 4 | — |
| SECONDARY Incidence of Treatment Failure by Treatment Group. |
34; 48 | 0.07 |
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.
Eligibility Criteria
Inclusion Criteria
- Children aged 7-18 years
- sickle cell anemia patient with severe acute painful crisis
- Parental consent and child assent where applicable
Exclusion Criteria
- Oxygen saturations below 90% on initial assessment
- Altered conscious and mental state that hinders communication
- Current enrollment in another clinical trial involving an investigational drug.
- History of a stroke
- Hypertension,
- Increased intracranial pressure.
- Glaucoma,
- Failed/ Difficult IV access
Data sourced from ClinicalTrials.gov (NCT02434939). 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.