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Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

Information source: Texas Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Children; Lacerations; Procedures; Child; Pain

Intervention: hydrocodone/acetaminophen (Drug); Sugar water (Drug)

Phase: N/A

Status: Completed

Sponsored by: Texas Children's Hospital

Official(s) and/or principal investigator(s):
Corrie Chumpitazi, MD, Principal Investigator, Affiliation: Texas Childrens Hospital

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

Clinical Details

Official title: Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Statistical difference in pain scores in children during laceration repair between study and placebo group

Secondary outcome: Statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores for children age 8-17 years during laceration repair

Detailed description: A prospective, double-blind, placebo-controlled, randomized clinical trial in a tertiary care pediatric emergency department with an annual census of 80,000 visits per year. Patients will be randomized by a randomization table with block randomization in the pharmacy to the oral narcotic or placebo group, and the pharmacist will be the only person aware of the randomization status of the patient. Allocation concealment will be ensured by opaque, sealed envelopes kept in the Emergency Department Pharmacy. Guardians of patients age 2 to 17 years of age will be consented for enrollment.

Eligibility

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 2 to 17 years

- Laceration of the skin and/or subcutaneous tissue requiring sutures

- American Society of Anesthesiologists (ASA) score of I or II

Exclusion Criteria:

- Major injuries in addition to laceration (suspected fracture, intracranial,

intrathoracic, or intraabdominal bleeding or organ injury)

- Abnormal neurologic examination (such as head injury)

- Severe congenital heart disease

- Pregnancy

- Known opiate or acetaminophen allergy

- Require conscious sedation

- Have had narcotic or acetaminophen administration within 4 previous hours

Locations and Contacts

Baylor College of Medicine, Houston, Texas 77030, United States
Additional Information

Starting date: February 2009
Last updated: May 11, 2015

Page last updated: August 23, 2015

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