Phase 2
N=62
Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis
Sickle Cell Disease · Vaso-Occlusive Crisis
Bottom Line
View on ClinicalTrials.gov: NCT03296345 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] — 0; 4; 4; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ketamine (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- UCSF Benioff Children's Hospital Oakland
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] |
0; 4; 4; 26; 3; 2 | — |
| SECONDARY Effect of Low-dose Ketamine (LDK) on Opioid Usage in the ED |
-15 | 0.004 sig |
| SECONDARY Effect of Low-dose Ketamine on Pain Scores on Presentation to the ED |
9.23; 9.08 | 0.38 |
| SECONDARY Effect of Low-dose Ketamine on Discharge Rates From the ED |
33; 17 | 0.58 |
| SECONDARY Subjective Effect of Low Dose Ketamine on Pain Relief Assessed Via a Patient Survey |
43; 30; 49 | — |
| SECONDARY Effect of Low-dose Ketamine on Patient Pain Scores on Discharge From the ED/Admission to the Hospital |
7.15; 7.26 | 0.76 |
| SECONDARY Effect of Low-dose Ketamine on Percent Difference of Length of Stay (LOS) in the ED |
273.5; 217.3 | — |
| SECONDARY Effect of Low-dose Ketamine on Time to 50% Pain Reduction |
116.1; 167.3 | — |
Summary
Acute vaso-occlusive episodes (VOEs) in sickle cell disease (SCD) are primarily managed with opioids. Tolerance and hyperalgesia to opioids develops due to N-methyl-D-aspartate (NMDA)-receptor mediated activation of the nociceptive system, and as a receptor antagonist, ketamine mitigates this. Intravenous (IV) ketamine has demonstrated efficacy in reducing post-operative, chronic, and cancer-related pain in pediatrics, as well as in reducing time to pain control in the emergency department (ED) in adults. Limited studies suggest efficacy in adult opioid-refractory SCD patients. This study is investigating the safety and tolerability of adjuvant low-dose IV ketamine bolus for pediatric SCD VOE in the ED, as well as its efficacy in improving pain control and reducing hospitalization.
Eligibility Criteria
Inclusion Criteria
- All English-speaking, sickle cell patients who receive their care at UCSFBCHO in the Department of Hematology who are 8-to-25-years-old presenting to the emergency department for VOC were asked to enroll.
Exclusion Criteria
- Prior adverse reaction to ketamine
- Patients were asked during the consent process if they have ever received ketamine, and if so, if they had any serious adverse reaction, such as difficulty breathing, dysphoria, hallucinations, or allergic reaction. If they have, ketamine was not given to these patients.
- Patients who have received ketamine and experienced nausea or vomiting will be asked if they wish to receive the medication. If they do not, they did not receive ketamine.
Data sourced from ClinicalTrials.gov (NCT03296345). 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.