N/A
N=278
Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients
Sickle Cell Crisis
Bottom Line
View on ClinicalTrials.gov: NCT03431285 ↗Enrolled (actual)
278
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Pain Scores — 5.6; 5.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Morphine Group (Drug); Ketamine Group (Drug); standard IV hydration (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imam Abdulrahman Bin Faisal University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores |
5.6; 5.7 | — |
| SECONDARY Length of Stay in ED |
4.8; 4.7 | — |
| SECONDARY Cumulative Use of Opioid |
0.13; 0.07 | — |
| SECONDARY The Rate of Hospital Admission |
34; 26 | — |
| SECONDARY Drug-related Adverse Effects |
3; 8 | — |
Summary
Investigators hypothesize that administration of ketamine for pain relief in sickle cell patients with vaso-occlusive crisis early on will lead to a more rapid improvement in pain score and less narcotic requirement.
Eligibility Criteria
Inclusion Criteria
- Known diagnosis of SCD based on sickle cell tests and hemoglobin electrophoresis.
- Age 18 to 60 years
- Acute onset of painful crises, defined as having an onset within 7 days
Exclusion Criteria
- Pregnancy
- Breast-feeding
- Altered mental status
- Body mass index greater than 40 kg/m2
- Patients with significant neurological disease
- Seizures
- Acute head injury
- Acute eye injury
- Patients with high intra-cranial tension
- Patients with known psychiatric disorders
- Patients with significant cardiac diseases
- Arrhythmias
- Patients with significant pulmonary diseases rather than acute chest syndrome
- Patients with significant renal disease (BUN/creatinine ratio < 25)
- Patients with significant hepatic disease (Child Pugh class B or C)
- Patients with significant endocrine disease
- Known allergy to phencyclidine derivatives
- Known allergy to ketamine
- Known allergy to morphine
- Sepsis
- Septic shock
- Patients required circulatory support
- Patients required ventilatory supports
- Alcohol abuse
- Drug abuse
- Patients with chronic pain status unrelated to SCD
- Patients receiving anti-convulsant medications
- Patients receiving anti-psychiatric medications.
- Patients with communication barriers.
Data sourced from ClinicalTrials.gov (NCT03431285). 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.