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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
Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having back surgery for scoliosis through an approach from the back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 postoperative hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 postoperative hours for reporting.

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 more

Trial 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
3,205 Previous Clinical Trials
3,768,108 Total Patients Enrolled
Kathryn Handlogten, MDPrincipal InvestigatorMayo Clinic

Media Library

Hydromorphone (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05552443 — Phase 4
Pain Management Research Study Groups: Intrathecal Hydromorphone 4.5 mcg/kg, Intrathecal Hydromorphone 2.5 mcg/kg, Intrathecal Hydromorphone 2.75 mcg/kg, Intrathecal Hydromorphone 3 mcg/kg, Intrathecal Hydromorphone 3.25 mcg/kg, Intrathecal Hydromorphone 3.5 mcg/kg, Intrathecal Hydromorphone 4 mcg/kg, Intrathecal Hydromorphone 5 mcg/kg
Pain Management Clinical Trial 2023: Hydromorphone Highlights & Side Effects. Trial Name: NCT05552443 — Phase 4
Hydromorphone (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05552443 — Phase 4

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
~14 spots leftby Dec 2024