NCT00583453

Celecoxib as a Post-tonsillectomy Pain Medication

Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use. To test this hypothesis, the study is placebo controlled (sugar pill). Half of the participants will receive a sugar pill, half will not. All participants will receive the standard post-operative pain medications. We ask participants to log the amount of medications they use daily, and the amount of pain they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain medication needed.

Detailed description

Post-tonsillectomy pain is typically controlled through narcotic medications, such as Lortab elixir. Despite its standard use, this pain control is typically not as effective as a non-steroidal anti-inflammatory medication (NSAID). The problem with using NSAIDs for post-tonsillectomy operative pain is the significant increased risk of rebleeding. Celecoxib is an NSAID that is a COX-2 inhibitor; the drug is designed to act as an NSAID without the increased risk of rebleeding or hemorrhage. This study is a double blind, randomized study; neither the study participant or the study investigator knows if the participant is receiving celecoxib or a placebo (sugar pill). The blinded list is maintained by the research pharmacists and can be unblinded when needed (such as in an emergency). Participants begin taking the study medication the night before surgery and continue through 10 days post-operative. Participants are asked to complete a journal that catalogs the amount of standard post-operative medications taken, the amount of pain experienced, and any other comments. Participants are contacted by phone at 5 and 10 days post-op. Study participation ends at the standard 3-week post-operative check-up.

Conditions

• Tonsillitis

Interventions

Type	Name	Description
DRUG	Celecoxib	Celecoxib 200 mg capsule 1. capsule the night before surgery 2. capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery
DRUG	Placebo	Placebo capsule 1. capsule the night before surgery 2. capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery

Timeline

• Start date: 2007-10-01
• Primary completion: 2013-12-01
• Completion: 2016-05-01
• First posted: 2007-12-31
• Last updated: 2017-03-29
• Results posted: 2017-03-29

Locations

1 site across 1 country: United States