Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults

NCT07369024 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-09

No results posted yet for this study

Summary

The purpose of this research is to see if ketamine is effective and safe in treating children and young adults with sickle cell disease experiencing sickle cell related pain. In this study, we will compare the outcomes (such as pain scores) in persons who receive standard of care pain medicine (an opioid such as morphine) plus a low dose (amount) of ketamine to those who receive only standard of care pain medicine.

Conditions

  • Sickle Cell Disease
  • Vaso-Occlusive Pain Episode in Sickle Cell Disease
  • Ketamine Infusion
  • Pain Management
  • Vaso-Occlusive Crises

Interventions

DRUG

Sub-dissociative Ketamine Infusion

0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)

DRUG

Normal Saline Placebo Infusion

20-minute infusion of 100 milliliters of normal saline

Sponsors & Collaborators

  • Mohsen Saidinejad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-31
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369024 on ClinicalTrials.gov