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Oral Ketamine for Sickle Cell Pain

Phase 3
Recruiting
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 12-24 years of age who require admission for vaso-occlusive pain
Be younger than 65 years old
Must not have
Patient refusal to participate
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and then every 4 hours for 48 hours
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test the feasibility of using oral ketamine to supplement IV opioids for the treatment of sickle-cell crises in children and adolescents.

Who is the study for?
This trial is for children and adolescents aged 12-24 who are admitted to the hospital with vaso-occlusive pain due to sickle cell crises. It's not for those who've had bad reactions to IV ketamine before or if they choose not to participate.
What is being tested?
The study tests oral ketamine as a supplement to IV opioids in managing severe pain during sickle-cell crises. Patients will take oral ketamine every 8 hours over two days, with continuous monitoring and evaluations by the Pain Service.
What are the potential side effects?
Possible side effects of oral ketamine may include changes in blood pressure, increased heart rate, nausea, vomiting, dizziness, hallucinations, and mood changes. Continuous monitoring aims to manage these risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 24 years old and need hospital care for pain from blocked blood vessels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not want to participate in the clinical trial.
Select...
I've had bad reactions to ketamine IV for pain before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and then every 4 hours for 48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and then every 4 hours for 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in pain intensity scores using the Visual Analogue Scale (VAS) Pain Score Scale
Secondary study objectives
Change in Sedation Scores using modified Ramsey Sedation Scores Scale
Frequency of side effects
Number of patients with abnormal vital signs

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504
1%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: KetamineExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,896 Total Patients Enrolled

Media Library

Ketamine Hydrochloride Clinical Trial Eligibility Overview. Trial Name: NCT05378555 — Phase 3
Sickle Cell Crisis Research Study Groups: Ketamine
Sickle Cell Crisis Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT05378555 — Phase 3
Ketamine Hydrochloride 2023 Treatment Timeline for Medical Study. Trial Name: NCT05378555 — Phase 3
~4 spots leftby Dec 2025
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