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Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01053637
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
Corrie Chumpitazi, Baylor College of Medicine

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

Condition or disease Intervention/treatment Phase
Children Lacerations Procedures Child Pain Drug: hydrocodone/acetaminophen Drug: Sugar water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department
Study Start Date : February 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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:
  • Lortab
  • Vicodin

Placebo Comparator: Sugar water
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

Primary Outcome Measures :
  1. Statistical difference in pain scores in children during laceration repair between study and placebo group [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores for children age 8-17 years during laceration repair [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01053637

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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
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Principal Investigator: Corrie Chumpitazi, MD Texas Childrens Hospital
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Responsible Party: Corrie Chumpitazi, Assistant Professor, Baylor College of Medicine Identifier: NCT01053637    
Other Study ID Numbers: H-22684
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Corrie Chumpitazi, Baylor College of Medicine:
Additional relevant MeSH terms:
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Wounds and Injuries
Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents