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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain intensity
Secondary study objectives
Incidence of antiemetic use postoperatively
Incidence of need for dual anti-pruritic agents
Maximum pain scores
+1 more

Awards & Highlights

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.

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
3,343 Previous Clinical Trials
3,062,309 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
~0 spots leftby Dec 2024
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