A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	10 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05552443
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kathryn Handlogten, MD
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pain Control

Additional Details

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.

Arms & Interventions

Arms

Experimental: Intrathecal Hydromorphone 2.5 mcg/kg

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

Experimental: Intrathecal Hydromorphone 2.75 mcg/kg

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

Experimental: Intrathecal Hydromorphone 3 mcg/kg

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

Experimental: Intrathecal Hydromorphone 3.25 mcg/kg

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

Experimental: Intrathecal Hydromorphone 3.5 mcg/kg

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

Experimental: Intrathecal Hydromorphone 4 mcg/kg

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

Experimental: Intrathecal Hydromorphone 4.5 mcg/kg

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

Experimental: Intrathecal Hydromorphone 5 mcg/kg

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic Rochester

Rochester, Minnesota, 55905

Site Contact

Kathryn Handlogten

[email protected]

507-255-5123

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