RecruitingPhase 3NCT05378555

Oral Ketamine for Treatment of Vaso-Occlusive Pain

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


Sponsor

Boston Children's Hospital

Enrollment

10 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 24 Years

Inclusion Criteria1

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

Exclusion Criteria2

  • Patients who have had side effects to previous use of intravenous ketamine for treatment of vaso-occlusive pain that would preclude using ketamine for future pain episodes.
  • Patient refusal to participate

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Interventions

DRUGKetamine Hydrochloride

All patients in this study will receive oral ketamine for the treatment of pain from vaso-occlusive crisis. Patients will receive 0.5 mg/kg ketamine Q8hrs for 48 hours.


Locations(1)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT05378555


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