Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

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

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

Study Overview

• Status: Completed
• Conditions: Pain; Lacerations; Child; Children; Procedures
• Intervention / Treatment: Drug: hydrocodone/acetaminophen; Drug: Sugar water

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrocodone/acetaminophen; Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.	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.; Other Names: Vicodin; Lortab
Placebo Comparator: Sugar water; Placebo	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group	Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest pain. This results in a 10 point scale of possible results, and is rated by an objective observer; the child life specialist at the bedside during the laceration repair. If the procedure was completed, there were no scores recorded at that time point.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale	State-Trait Anxiety Inventory for Children - 20 questions with 3 answer options for each question. Scores range from 20 to 60 for state and 20 to 60 for trait with 60 being the higher (more or worse) anxiety on self-assessment. The VAS pain Scale from 0-10 was included in this older population as well.	1 hour approximately (survey was given pre and post procedure so from 15 minutes to 1 hour after initial survey (or 5 minutes to 45 minutes after the procedure).
Visual Analog Scale (VAS) Pain Score for Children > 7 Years.	Visual Analog Scale from 0-10 as marked on a 10 cm line. 0 no pain, 10 worst pain. A child >7 group marks their pain on the line, and a mm measurement is made. Power based on a change in the Visual Analog Scale (VAS) for children > 7 years. A change in pain score of 10 mm (95% Confidence Interval 7-12 mm) was considered to be clinically significant based upon a previous study.	30 minutes

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Corrie Chumpitazi, MD, Texas Childrens Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 20, 2010
• First Posted (Estimate): January 21, 2010

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pediatrics; pain; Anxiety; child; sutures; lacerations
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Hydrocodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: H-22684