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Opioid Analgesic
Intrathecal Hydromorphone for Pain Management in Scoliosis Repair
Phase 4
Recruiting
Led By Kathryn Handlogten, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 postoperative hours
Awards & highlights
Study Summary
This trial is testing different doses of an opioid pain medication to find the best balance of pain relief and side effects.
Who is the study for?
This trial is for children undergoing spinal surgery for idiopathic scoliosis. They must not have high pre-surgery pain scores, a history of chronic pain or opioid use, and no risk factors that make spinal anesthesia unsafe like certain anatomical abnormalities or increased bleeding/infection risks.Check my eligibility
What is being tested?
The study is testing different doses of intrathecal hydromorphone (an opioid pain medication) to find the best balance between effective pain control and minimal side effects in pediatric patients after scoliosis repair surgery.See study design
What are the potential side effects?
Hydromorphone can cause side effects such as nausea, vomiting, constipation, drowsiness, itching, and respiratory depression. The trial aims to determine which dose manages pain with the fewest side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 postoperative hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 postoperative hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain intensity
Secondary outcome measures
Incidence of antiemetic use postoperatively
Incidence of need for dual anti-pruritic agents
Maximum pain scores
+1 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Intrathecal Hydromorphone 5 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group II: Intrathecal Hydromorphone 4.5 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group III: Intrathecal Hydromorphone 4 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group IV: Intrathecal Hydromorphone 3.5 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group V: Intrathecal Hydromorphone 3.25 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group VI: Intrathecal Hydromorphone 3 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group VII: Intrathecal Hydromorphone 2.75 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group VIII: Intrathecal Hydromorphone 2.5 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,211 Previous Clinical Trials
3,766,958 Total Patients Enrolled
Kathryn Handlogten, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have conditions that make spinal anesthesia risky for me.I am having back surgery for scoliosis through an approach from the back.I do not have chronic pain, haven't used opioids before surgery, and my pain score is below 3.
Research Study Groups:
This trial has the following groups:- Group 1: Intrathecal Hydromorphone 4.5 mcg/kg
- Group 2: Intrathecal Hydromorphone 2.5 mcg/kg
- Group 3: Intrathecal Hydromorphone 2.75 mcg/kg
- Group 4: Intrathecal Hydromorphone 3 mcg/kg
- Group 5: Intrathecal Hydromorphone 3.25 mcg/kg
- Group 6: Intrathecal Hydromorphone 3.5 mcg/kg
- Group 7: Intrathecal Hydromorphone 4 mcg/kg
- Group 8: Intrathecal Hydromorphone 5 mcg/kg
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Are geriatric individuals eligible to enroll in this research endeavor?
"This trial has an age-range restriction of 10 to 17 years old that all participants must meet in order to be eligible."
Answered by AI
Has the federal regulatory body sanctioned Intrathecal Hydromorphone 3.5 mcg/kg for usage?
"After review, the safety of Intrathecal Hydromorphone 3.5 mcg/kg was rated a 3, as this is an approved Phase 4 trial."
Answered by AI
What types of individuals are suitable for this clinical trial?
"The parameters for this clinical trial include pain and an age range between 10 and 17; 40 applicants are needed to reach the maximum capacity of the study."
Answered by AI
Are there any positions available to volunteer for this clinical trial?
"Presently, the information published on clinicaltrials.gov reveals that this study is not looking for any new participants. This trial was initially advertised on November 1st 2022 and subsequently updated nine months later (September 2020). Although there are no current openings in this research project, 78 other studies have open enrollment at present."
Answered by AI
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