Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-04-13 @ 10:45 PM
Study NCT ID:
NCT00847093
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2009-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery
Sponsor:
Ferndale Laboratories, Inc.
Organization:
Study Overview
Official Title:
Post-Operative Pain Control in Children and Infants Undergoing Penoplasty: A Randomized Control Trial of a Local Anesthetic Cream Placebo.
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LMX-4
Brief Summary:
After surgery on his penis, your child will probably have some pain. The investigators will give you a prescription for acetaminophen (Tylenol) with codeine, given by mouth (orally), for pain. In this study, the investigators want to see if a local anesthetic cream applied to the base of the shaft of the penis can reduce the need for oral medicine .
Detailed Description:
Your child will receive a general anesthetic for the surgery. After your child is asleep, he will receive a local anesthetic injection in the area of the tailbone (normal procedure for this surgery). At the end of the operation your child will go to the recovery room. At the time of discharge from the hospital, we will be give you the prescription for acetaminophen with codeine (standard medication given for children undergoing surgery on the penis), and a tube of cream. The tube will contain either a local anesthetic cream (LMX-4)® or a cream with no active medicine (a placebo). We want you to apply the cream to the base of your son's penis every six hours. Which kind of tube you get will be picked randomly (similar to drawing numbers out of a hat) by a computer. Thirty minutes after applying the study cream, or sooner if needed, if you think your child needs pain medication, you may give the oral pain medicine (Tylenol with codeine as prescribed on the bottle). You may continue to apply the cream and give oral medicine every six hours as long as you think your child needs pain medicine for a maximum of 7 days. The cream can also be re-applied when changing diapers to facilitate the continued use of the cream even if it is sooner than the suggested 6 hours.
Study Oversight
Has Oversight DMC:
False
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?: