A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

Identification of the Optimal Analgesic Dose of Intrathecal Hydromorphone for Pediatric Patients Undergoing Posterior Spine Surgery for Idiopathic Scoliosis

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05552443

Enrollment

Registered

2022-09-23

Start date

2023-03-23

Completion date

2024-12-31

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Control

Keywords

Posterior Spine Surgery, Pediatric Idiopathic Scoliosis Repair

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.

Detailed description

This study is a sequential coin based up-down dose allocation method with the goal of identifying the ED90 for intrathecal hydromorphone (ITH) in idiopathic adolescent scoliosis repair via the posterior approach. A starting dose of 3.5 mcg/kg of hydromorphone was determined by current practice at the institution as well as upon review of available literature of previously used ITM doses in pediatric spine patients. Subsequent participants will receive higher (step "up") or lower (step "down") from this starting dose. Steps "down" from the starting dose will be smaller than steps "up" to ensure maintenance of adequate analgesia and to allow more accurate estimate of the optimal dose should it decrease beyond our starting dose. Steps "up" from the starting dose were chosen based on commonly used weight-based doses in our current practice. A maximum dose of 400 mcg, despite patient weight, was determined based on expert consensus and review preparatory to research query. Each patient was assigned to a weight-based dose arm, between 3.5mcg/kg-7.0mcg/kg or up to a maximum of 400 mcg. The anesthesiologist covering the case (high lumbar or thoracic corrections) or the surgeon (low lumbar corrections) will administer the medication at the low lumbar level. ITH dose adjustments for subsequent study patients will be based on the efficacy of the dose used with the prior patient. Efficacious ITH administration will be defined as all NRS scores ≤5 within the first 18 hours after administration (binary outcome). If the NRS score was \>5 within 18 hours or if the patient required supplemental opioid administration for pain control (suggestive of insufficient analgesia), the dose will be increased for the next enrolled study patient. If the pain score remains ≤5 within 18 hours of opioid administration, the next patient will receive the next lower dose or the same dose as the previous patient. Patients excluded after randomization will be removed from the study.

Interventions

DRUGHydromorphone 2.5 mcg/kg

2.5 mcg/kg intrathecal

DRUGHydromorphone 2.75 mcg/kg

2.75 mcg/kg intrathecal

DRUGHydromorphone 3 mcg/kg

3 mcg/kg intrathecal

DRUGHydromorphone 3.25 mcg/kg

3.25 mcg/kg intrathecal

DRUGHydromorphone 3.5 mcg/kg

3.5 mcg/kg intrathecal

DRUGHydromorphone 4 mcg/kg

4 mcg/kg intrathecal

DRUGHydromorphone 4.5 mcg/kg

4.5 mcg/kg intrathecal

DRUGHydromorphone 5 mcg/kg

5 mcg/kg intrathecal

DRUGHydromorphone 5.5 mcg/kg

5.5 mcg/kg intrathecal

DRUGHydromorphone 6 mcg/kg

6 mcg/kg intrathecal

DRUGHydromorphone 6.5 mcg/kg

6.5 mcg/kg intrathecal

DRUGHydromorphone 7 mcg/kg

7 mcg/kg intrathecal

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Pain Intensity (Area Under the Curve Pain)	18 hours after intrathecal hydromorphone administration	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.

Secondary

Measure	Time frame	Description
Number of Subjects Needing Dual Anti-pruritic Agents	24 postoperative hours	The number of subjects who needed dual anti-pruritic agents (Nubain or naloxone (beyond the protocol infusion rate of 0.25 mcg/kg/min)).
Maximum Pain Scores	18 hours after intrathecal hydromorphone administration	Highest pain score reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with total scores ranging from 0=no pain and 10=worst pain ever with higher scores indicating more severe pain.
Oral Morphine Equivalents Consumption	24 hours after intrathecal hydromorphone administration	Total oral morphine equivalents (OME) consumption in the first 24 hours after intrathecal hydromorphone administration. Intrathecal hydromorphone will be included in total oral morphine equivalents consumption.
Number of Subjects Needing Antiemetic Medications Postoperatively	24 postoperative hours	The number of subjects who needed antiemetic medications to prevent or treat nausea and vomiting.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKathryn Handlogten, MD

Mayo Clinic

Participant flow

Recruitment details

There were 31 subjects consented to the study, one of which was withdrawn from the study before study group assignment occurred.

Pre-assignment details

0 in 2.5-3.25mcg/kg arms as SDMS didn't assign subjects to those doses due to ITH dose for 1st subject being 3.5mcg/kg and subsequent subjects dose assignmts following a biased-coin up-down sequential allocation design. Adjustments made in 0.5mcg/kg increments based on efficacy defined asNRS≤5 within18hrs post-ITH. If subject had NRS\>5,the next subject received next higher dose.If subject had NRS≤5,next subject had0.89 chance of receiving same dose and0.11 chance of receiving next lower dose.

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	8 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	26 Participants
Region of Enrollment Canada	0 participants
Region of Enrollment United States	29 participants
Sex: Female, Male Female	21 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 1	0 / 3	0 / 4	0 / 5	0 / 6	0 / 8
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	1 / 1	0 / 1	0 / 3	1 / 4	1 / 5	0 / 6	1 / 8
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 1	0 / 3	0 / 4	0 / 5	0 / 6	0 / 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026