Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

Baylor College of Medicine

Status: Completed

Conditions: Child; Lacerations; Procedures; Children; Pain

Treatments: Drug: Sugar water; Drug: hydrocodone/acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT01053637

H-22684

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 2 patient groups, including a placebo group

Hydrocodone/acetaminophen

Experimental group

Description:

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

Treatment:

Drug: hydrocodone/acetaminophen

Sugar water

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Sugar water