Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01268670
Status:
SUSPENDED
Last Update Posted:
2013-07-31
First Post:
2010-12-29
Brief Title:
The Addition of Oral Analgesics to LET During Laceration Repair
Sponsor:
Childrens Hospitals and Clinics of Minnesota
Organization:
Childrens Hospitals and Clinics of Minnesota
Study Overview
Official Title:
Adjunctive Oral Analgesia for Laceration Repair Assessing Pain in a Pediatric Emergency Department
Status:
SUSPENDED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study is currently suspended due to transition of the investigator
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None