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Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain

NCT03537612 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-11-22

No results posted yet for this study

Summary

The overall goal of this proposal is to determine if quantitative sensory testing (QST) assessing pain modulation can be used as a clinical tool to optimize perioperative pain management. The central hypothesis is that the identification of patient's sensory pain profile allows personalizing therapeutic approaches to improve individualized pain management and thus prevents pain chronicity.

Conditions

  • Scoliosis

Interventions

DRUG

Clonidine

Intrathecal Clonidine 1 mcg/kg (up to 75 mcg) immediatey post-op; 100 mcg capsule TID Post op day 1-5 (liquid version available if subject cannot swallow capsule)

OTHER

Morphine

Intrathecal spinal morphine (5 mcg / kg) immediatey post-op; Placebo capsule TID Post op day 1-5 (liquid version available if subject cannot swallow capsule)

Sponsors & Collaborators

  • Dr. Jean A. Ouellet, MD, FRCSC

    lead OTHER

Principal Investigators

  • Jean A Ouellet, MD · Shriners Hospital for Children - Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2022-04-05
Completion
2022-04-05

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03537612 on ClinicalTrials.gov