A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

NCT05552443 | Terminated Phase 4 FDA Drug

• 1 other identifier: 22-006823
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.

Conditions

Pain Control

Keywords

Posterior Spine Surgery; Pediatric Idiopathic Scoliosis Repair

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Reported by the patient using an 11-point numeric visual analogue scale (NRS) with 0=no pain and 10=worst pain ever

  18 hours after intrathecal hydromorphone administration

Secondary Outcomes (4)

• Incidence of need for dual anti-pruritic agents

  24 postoperative hours

• Maximum pain scores

  24 hours after intrathecal hydromorphone administration

• OME consumption

  24 hours after intrathecal hydromorphone administration

• Incidence of antiemetic use postoperatively

  24 postoperative hours

Study Arms (8)

Intrathecal Hydromorphone 2.5 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 2.5 mcg/kg

Intrathecal Hydromorphone 2.75 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 2.75 mcg/kg

Intrathecal Hydromorphone 3 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 3 mcg/kg

Intrathecal Hydromorphone 3.25 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 3.25 mcg/kg

Intrathecal Hydromorphone 3.5 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 3.5 mcg/kg

Intrathecal Hydromorphone 4 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 4 mcg/kg

Intrathecal Hydromorphone 4.5 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 4.5 mcg/kg

Intrathecal Hydromorphone 5 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 5 mcg/kg

Interventions

Hydromorphone 2.5 mcg/kg DRUG

2.5 mcg/kg intrathecal

Intrathecal Hydromorphone 2.5 mcg/kg

Hydromorphone 2.75 mcg/kg DRUG

2.75 mcg/kg intrathecal

Intrathecal Hydromorphone 2.75 mcg/kg

Hydromorphone 3 mcg/kg DRUG

3 mcg/kg intrathecal

Intrathecal Hydromorphone 3 mcg/kg

Hydromorphone 3.25 mcg/kg DRUG

3.25 mcg/kg intrathecal

Intrathecal Hydromorphone 3.25 mcg/kg

Hydromorphone 3.5 mcg/kg DRUG

3.5 mcg/kg intrathecal

Intrathecal Hydromorphone 3.5 mcg/kg

Hydromorphone 4 mcg/kg DRUG

4 mcg/kg intrathecal

Intrathecal Hydromorphone 4 mcg/kg

Hydromorphone 4.5 mcg/kg DRUG

4.5 mcg/kg intrathecal

Intrathecal Hydromorphone 4.5 mcg/kg

Hydromorphone 5 mcg/kg DRUG

5 mcg/kg intrathecal

Intrathecal Hydromorphone 5 mcg/kg

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.

You may not qualify if:

• Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included.
• Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included.
• Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Agnosia

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Kathryn Handlogten, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: March 23, 2023
• Primary Completion: October 27, 2024
• Study Completion: December 31, 2024
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)