CompletedNot Applicable

Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

United States57 participantsStarted 2013-03

Plain-language summary

The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.

Who can participate

Age range1 Year – 7 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 1 year to \< 8 years * Undergoing strabismus surgery under general anesthesia * No previous surgery on muscle to be operated * No known allergy to lidocaine or bupivacaine * Investigator willing to inject subtenons NS or preservative-free bupivacaine 0.75% by cannula into all surgical wounds and willing to administer topical lidocaine 3.5% ophthalmic gel or Hypromellose 0.3% gel (GenTeal Severe Dry Eye Relief) to all surgical wounds at the end of strabismus surgery.

What they're measuring

Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale

Timeframe: 0-30 minutes post-operative

Trial details

NCT IDNCT01812044

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

Results submitted2015-12-01

View on ClinicalTrials.gov More Strabismus trials