Ketamine Hydrochloride for Vaso-occlusive Crisis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Boston Children's Hospital, Boston, MA
Vaso-occlusive Crisis
Ketamine Hydrochloride - Drug
Eligibility
< 65
All Sexes
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Study Summary

The purpose of this study is to learn more about the feasibility of oral ketamine for the treatment of painful sickle-cell crises in children and adolescents as a supplement to intravenous (IV) opioids. There is a need for improved non-opioid analgesia for patients experiencing sickle-cell crises in the hospital and prehospital setting, as children and adolescents with sickle cell disease who experience sickle-cell crises often have severe pain that is not well controlled by high dose opioids, leading to poor pain management and opioid-related side effects. The study will begin when patients are admitted to the Emergency Department of Boston Children's Hospital for treatment of a sickle-cell crisis. Oral ketamine will be administered every 8 hours for the next 48 hours. Patients will have continuous cardiorespiratory monitoring for the duration of the study, as per routine care, as well as monitoring by the hospital's Acute Pain Service at least twice daily for pain management and side effects of pain treatment. At the end of the 48-hour study duration, patients will discuss with the Pain Service and Hematology Service whether to continue oral ketamine, change to intravenous ketamine, or discontinue ketamine based on clinical indications such as level of pain and sedation while on opioids.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Vaso-occlusive Crisis

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline, and then every 4 hours for 48 hours

Hour 48
Change in Sedation Scores using modified Ramsey Sedation Scores Scale
Change in pain intensity scores using the Visual Analogue Scale (VAS) Pain Score Scale
Frequency of side effects
Number of patients with abnormal vital signs

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Vaso-occlusive Crisis

Side Effects for

Ketamine
1%Lightheadedness with low blood pressure
1%PTSD
1%Pump Malfunction
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03156504) in the Ketamine ARM group. Side effects include: Lightheadedness with low blood pressure with 1%, PTSD with 1%, Pump Malfunction with 1%.

Trial Design

1 Treatment Group

Ketamine
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Ketamine Hydrochloride · No Placebo Group · Phase 3

Ketamine
Drug
Experimental Group · 1 Intervention: Ketamine Hydrochloride · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~570

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, and then every 4 hours for 48 hours
Closest Location: Boston Children's Hospital · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2020First Recorded Clinical Trial
2 TrialsResearching Vaso-occlusive Crisis
351 CompletedClinical Trials

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
704 Previous Clinical Trials
5,310,929 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References