A Pilot Study of the Use of Oral Ketamine for Treatment of Vaso-Occlusive Pain in Adolescents and Young Adults

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 24
Healthy Volunteers: f
View:

• Patients 12-24 years of age who require admission for vaso-occlusive pain

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Christine Greco, MD
christine.greco@childrens.harvard.edu
857-218-3556
Backup
Kimberly Lobo, MPH
kimberly.lobo@childrens.harvard.edu
857-218-3556
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 10
Treatments
Experimental: Ketamine
Sponsors
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov