A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

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

Interventions

DRUG

Hydromorphone 2.5 mcg/kg

2.5 mcg/kg intrathecal

DRUG

Hydromorphone 2.75 mcg/kg

2.75 mcg/kg intrathecal

DRUG

Hydromorphone 3 mcg/kg

3 mcg/kg intrathecal

DRUG

Hydromorphone 3.25 mcg/kg

3.25 mcg/kg intrathecal

DRUG

Hydromorphone 3.5 mcg/kg

3.5 mcg/kg intrathecal

DRUG

Hydromorphone 4 mcg/kg

4 mcg/kg intrathecal

DRUG

Hydromorphone 4.5 mcg/kg

4.5 mcg/kg intrathecal

DRUG

Hydromorphone 5 mcg/kg

5 mcg/kg intrathecal

DRUG

Hydromorphone 5.5 mcg/kg

5.5 mcg/kg intrathecal

DRUG

Hydromorphone 6 mcg/kg

6 mcg/kg intrathecal

DRUG

Hydromorphone 6.5 mcg/kg

6.5 mcg/kg intrathecal

DRUG

Hydromorphone 7 mcg/kg

7 mcg/kg intrathecal

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Kathryn Handlogten, MD · Mayo Clinic

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

10 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-23

Primary Completion

2024-10-27

Completion

2024-12-31

FDA Drug

Yes

Countries

• United States

Study Locations