LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery
| Status: | Archived |
|---|---|
| Conditions: | Post-Surgical Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2008 |
| End Date: | July 2009 |
Post-Operative Pain Control in Children and Infants Undergoing Penoplasty: A Randomized Control Trial of a Local Anesthetic Cream Placebo.
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 .
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.
We found this trial at
1
site
9300 Valley Children's Pl
Madera, California 93720
Madera, California 93720
(559) 353-3000
Children's Hospital Central California The Children's Hospital Central California is a not-for-profit, state-of-the-art children’s hospital...
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