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Completed

NCT Number: NCT01053637

Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

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

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Key information

Conditions

Children Anxiety Disorders Child Lacerations Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Procedures Signs and Symptoms Wounds and Injuries

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocodone/Acetaminophen

Drug

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: Lortab, Vicodin

Sugar water

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

Primary outcomes

  1. Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group

    Time frame: 5 minutes

    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.

Secondary outcomes

  1. Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale

    Time frame: 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).

    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.

  2. Visual Analog Scale (VAS) Pain Score for Children > 7 Years.

    Time frame: 30 minutes

    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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
Jan 21, 2010
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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