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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and then every 4 hours for 48 hours
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 12 and 24 years old and need hospital care for pain from blocked blood vessels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, and then every 4 hours for 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and then every 4 hours for 48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pain intensity scores using the Visual Analogue Scale (VAS) Pain Score Scale
Secondary outcome measures
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 • NCT031565041%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine
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
761 Previous Clinical Trials
5,579,720 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not want to participate in the clinical trial.I am between 12 and 24 years old and need hospital care for pain from blocked blood vessels.I've had bad reactions to ketamine IV for pain before.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for participants in this trial 85 years or older?
"The ideal candidates for this study must be aged between 12 and 24 years old."
Answered by AI
Is Ketamine Hydrochloride a safe medication?
"There is some clinical evidence to suggest ketamine hydrochloride is effective, as well as multiple reports indicating it is safe, so it received a score of 3."
Answered by AI
Could you provide more information on how to sign up for the clinical trial?
"This study, which was initially posted on June 1st, is not recruiting patients at this time. The last update was on May 16th. There are other trials that are recruiting patients."
Answered by AI
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