Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

NCT ID: NCT01053637

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2015-05-31

Brief 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

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.

Conditions

Children; Lacerations; Procedures; Child; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hydrocodone/acetaminophen

Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.

Group Type: EXPERIMENTAL

hydrocodone/acetaminophen

Intervention Type: DRUG

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

Sugar water

Placebo

Group Type: PLACEBO_COMPARATOR

Sugar water

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Lortab; Vicodin

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Corrie Chumpitazi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corrie Chumpitazi, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Childrens Hospital

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

H-22684

Identifier Type: -

Identifier Source: org_study_id