A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

Pain Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552443
• Other study ID #: 22-006823
• Status: Recruiting
• Phase: Phase 4
• Start date: March 23, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Control
• Scoliosis

Intervention

Drug:
• Hydromorphone 2.5 mcg/kg
2.5 mcg/kg intrathecal
• Hydromorphone 2.75 mcg/kg
2.75 mcg/kg intrathecal
• Hydromorphone 3 mcg/kg
3 mcg/kg intrathecal
• Hydromorphone 3.25 mcg/kg
3.25 mcg/kg intrathecal
• Hydromorphone 3.5 mcg/kg
3.5 mcg/kg intrathecal
• Hydromorphone 4 mcg/kg
4 mcg/kg intrathecal
• Hydromorphone 4.5 mcg/kg
4.5 mcg/kg intrathecal
• Hydromorphone 5 mcg/kg
5 mcg/kg intrathecal

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of need for dual anti-pruritic agents	Number of subjects needing dual anti-pruritic agents (Nubain or naloxone (beyond the protocol infusion rate of 0.25 mcg/kg/min))	24 postoperative hours
Secondary	Maximum pain scores	Highest pain score reported during the first 24 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.	24 hours after intrathecal hydromorphone administration
Secondary	OME consumption	Total oral morphine equivalents (OME) consumption	24 hours after intrathecal hydromorphone administration
Secondary	Incidence of antiemetic use postoperatively	Number of subjects to require antiemetic medications used to prevent or treat nausea and vomiting	24 postoperative hours