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NCT05378555CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 28 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
10 (actual)
First submitted
6 Apr 2022
Start date
26 May 2023
Primary completion date
21 Nov 2025
Lead sponsor
Boston Children's Hospital
NCT number
NCT05378555

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 10
  • From 26 May 2023 to the primary completion date, 21 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • Patient refusal to participate

Who the study is looking for

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

Age in the registry: 12 years to 24 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Boston Children's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.