A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

NCT05552443 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 22-006823
• Study Type: interventional
• Target: 31
• 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 (Area Under the Curve Pain)

  Pain intensity reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with 0=no pain and 10=worst pain ever. Subjects were asked to rate their pain approximately 9 different times within the first 18 hours after intrathecal hydromorphone administration. The sum of the patients' pain scores was calculated to determine pain intensity. Total scores ranging from 0 to 90 with higher scores indicating more severe pain. Pain scores over the first 18 hours were used to calculate the Area Under the Curve (AUC) using the trapezoidal rule.

  18 hours after intrathecal hydromorphone administration

Secondary Outcomes (4)

• Number of Subjects Needing Dual Anti-pruritic Agents

  24 postoperative hours

• Maximum Pain Scores

  18 hours after intrathecal hydromorphone administration

• Oral Morphine Equivalents Consumption

  24 hours after intrathecal hydromorphone administration

• Number of Subjects Needing Antiemetic Medications Postoperatively

  24 postoperative hours

Study Arms (12)

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

Intrathecal Hydromorphone 5.5 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 5.5 mcg/kg

Intrathecal Hydromorphone 6 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 6 mcg/kg

Intrathecal Hydromorphone 6.5 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 6.5 mcg/kg

Intrathecal Hydromorphone 7 mcg/kg

EXPERIMENTAL

Subjects undergoing posterior spinal surgery will receive 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Drug: Hydromorphone 7 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

Hydromorphone 5.5 mcg/kg DRUG

5.5 mcg/kg intrathecal

Intrathecal Hydromorphone 5.5 mcg/kg

Hydromorphone 6 mcg/kg DRUG

6 mcg/kg intrathecal

Intrathecal Hydromorphone 6 mcg/kg

Hydromorphone 6.5 mcg/kg DRUG

6.5 mcg/kg intrathecal

Intrathecal Hydromorphone 6.5 mcg/kg

Hydromorphone 7 mcg/kg DRUG

7 mcg/kg intrathecal

Intrathecal Hydromorphone 7 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

Limitations and Caveats

This study was terminated early as a study participant had a related adverse event that prompted interim data analysis and additional study participants were not sought.

Results Point of Contact

• Title: Kathryn Handlogten, M.D.
• Organization: Mayo Clinic

handlogten.kathryn@mayo.edu

507-255-4236

Study Officials

• Kathryn Handlogten, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: May 14, 2026
• Results First Posted: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)