A Comparison of UGSB and GA to IV Narcotics and GA for Post-Op Pain in Children With Supracondylar Fractures.

NCT02056288 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-05-21

Study results available
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Summary

This study compares nerve blocks to IV pain medicines in children with broken arms. We are trying to see if blocking the nerves in the broken arm results in better pain control and less side effects than injections of morphine into a vein after surgery for a broken elbow.

Conditions

  • Supracondylar Fractures

Interventions

DRUG

Fentanyl

Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.

DRUG

Ropivacaine

Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Chris Glover, MD · Baylor College of Medicine

  • Melissa Challman, MPH · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-10
Primary Completion
2019-02-11
Completion
2019-03-01

Countries

  • United States

Study Locations

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Entities

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 NCT02056288 on ClinicalTrials.gov