Clinical Trials Logo
  1. Home
  2. Post-operative Pain
  3. NCT00847093

LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery — LMX-4  

Post-Operative Pain Clinical Trial

Official title:
Post-Operative Pain Control in Children and Infants Undergoing Penoplasty: A Randomized Control Trial of a Local Anesthetic Cream Placebo.

Clinical Trial 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 .

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00847093
Study type Interventional
Source Ferndale Laboratories, Inc.
Contact
Status Completed
Phase Phase 4
Start date September 2008
Completion date July 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT02489526 - Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery Phase 2
Completed NCT05635916 - Trial of Liposomal Bupivacaine for TKA Phase 4
Terminated NCT05146453 - Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology Phase 4
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Not yet recruiting NCT03591172 - Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization N/A
Completed NCT01667445 - Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty Phase 4
Completed NCT01686802 - Post-operative Oral Morphine Versus Ibuprofen Phase 2
Completed NCT01444924 - Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery Phase 2
Completed NCT00968955 - Effect of Local Infiltration Analgesia in Total Hip Arthroplasty Phase 4
Completed NCT00830089 - Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery N/A
Terminated NCT00875862 - Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks Phase 4
Completed NCT00390312 - Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction Phase 2
Recruiting NCT05278494 - Dextromethorphan for Treatment of Postoperative Pain N/A
Recruiting NCT05973045 - Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy N/A
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A
Enrolling by invitation NCT04346407 - Dronabinol for Post-operative Pain After Lumbar Fusion Phase 4
Completed NCT03635515 - Occurrence of Post-op Pain Following Gentlewave N/A
Terminated NCT03201809 - Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial N/A
Completed NCT03254056 - Fascial Closure Techniques Post-Operative Pain Laparoscopy N/A
Not yet recruiting NCT02555423 - The Effects of Serratus Plane Block Performed Under Direct Vision on Post-operative Pain in Breast Surgery N/A