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Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

NCT01053637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2021-08-25

Study results available
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Summary

The purpose of this study is:

* To determine whether oral narcotic medication versus placebo improves the pain and anxiety scores for pediatric patients requiring laceration repair in the pediatric emergency department and receiving the standard of care with lidocaine treatment
* To evaluate for a statistical difference in pain scores in children during laceration repair
* To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores during laceration repair

Conditions

  • Children
  • Lacerations
  • Procedures
  • Child
  • Pain

Interventions

DRUG

hydrocodone/acetaminophen

0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.

DRUG

Sugar water

An equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Corrie Chumpitazi, MD · Texas Childrens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-01-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01053637 on ClinicalTrials.gov