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The Addition of Oral Analgesics to LET During Laceration Repair

Primary Purpose

Laceration, Pain

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Oxycodone
Placebo
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laceration

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English-speaking patients
  • Patients 4 years of age up to 10 years of age
  • Patients seen in the ED needing simple facial laceration repair
  • Patients with no chronic medical problems

Exclusion Criteria:

  • Any patient who's parent or primary caretaker refuses consent
  • Any patient who's parent or primary caretaker needs an interpreter
  • Any child with complex laceration(s) or bites
  • Any child who has received pain medication at home in response to the facial laceration.
  • Children needing procedural sedation
  • Children with a known allergy to lidocaine, epinephrine, tetracaine, ibuprofen, or oxycodone
  • Patients with known or pre-existing medical conditions where the study protocol cannot be used
  • This includes any patient with a medical condition that prevents appropriate use of the pain scale
  • It also includes patients with medical conditions that warrant the use of chronic medications

Sites / Locations

  • Children's Hospitals and Clinics of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ibuprofen

Oxycodone

Placebo

Arm Description

Subjects will receive topical LET and oral ibuprofen.

Subjects will receive topical LET and oral oxycodone.

Subjects will receive topical LET and oral placebo.

Outcomes

Primary Outcome Measures

Pain scores
The use of adjunctive oral analgesics for facial/scalp laceration repair decrease pain scores more effectively than LET alone.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2010
Last Updated
July 30, 2013
Sponsor
Children's Hospitals and Clinics of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01268670
Brief Title
The Addition of Oral Analgesics to LET During Laceration Repair
Official Title
Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Suspended
Why Stopped
This study is currently suspended due to transition of the investigator.
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota

4. Oversight

5. Study Description

Brief Summary
Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. While topical numbing medications are effective, children often require further pain control during laceration repair in the form of an injected numbing medication, which in itself is painful. No evidence currently exists regarding the concurrent use of oral pain medications to combat laceration procedural pain. Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during laceration repair? Design This is a double-blinded, randomized-controlled study. Methods Subjects in all three groups will receive topical anesthetic. In addition to topical anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or oxycodone, while the third group will receive a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Subjects will receive topical LET and oral ibuprofen.
Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Description
Subjects will receive topical LET and oral oxycodone.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive topical LET and oral placebo.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Subjects will receive topical LET and oral ibuprofen.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Subjects will receive topical LET and oral oxycodone.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive topical LET and oral placebo.
Primary Outcome Measure Information:
Title
Pain scores
Description
The use of adjunctive oral analgesics for facial/scalp laceration repair decrease pain scores more effectively than LET alone.
Time Frame
At Triage, after first suture, and the worst during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English-speaking patients Patients 4 years of age up to 10 years of age Patients seen in the ED needing simple facial laceration repair Patients with no chronic medical problems Exclusion Criteria: Any patient who's parent or primary caretaker refuses consent Any patient who's parent or primary caretaker needs an interpreter Any child with complex laceration(s) or bites Any child who has received pain medication at home in response to the facial laceration. Children needing procedural sedation Children with a known allergy to lidocaine, epinephrine, tetracaine, ibuprofen, or oxycodone Patients with known or pre-existing medical conditions where the study protocol cannot be used This includes any patient with a medical condition that prevents appropriate use of the pain scale It also includes patients with medical conditions that warrant the use of chronic medications
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis and St Paul
State/Province
Minnesota
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Addition of Oral Analgesics to LET During Laceration Repair

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