Celecoxib as a Post-tonsillectomy Pain Medication

Tonsillitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00583453
• Other study ID #: 200703765
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: December 11, 2013
• Start date: July 2007
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age at least 18 years

• Indication for tonsillectomy (patients undergoing a tonsillectomy as a portion of additional surgical procedures will not be included)

• Have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• History of bleeding disorders

• History of liver or kidney dysfunction

• History of allergy to sulfa containing medications

• History of lactose intolerance

• History of asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs

• Women who are currently pregnant, nursing, or trying to conceive

• History of allergy or intolerance to acetaminophen or hydrocodone

• History of allergy to any COX-2 inhibitor, including celecoxib or rofecoxib.

• PT, PTT, hemoglobin, or hematocrit values that are outside of institutional limits.

• History of cardiovascular disease

• Patients currently taking celecoxib

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Tonsillitis

Intervention

Drug:
• Celecoxib
Celecoxib 200 mg capsule capsule the night before surgery capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery
• Placebo
Placebo capsule capsule the night before surgery capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery

Locations

Country	Name	City	State
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare analgesia in subjects receiving celecoxib versus placebo		throughout 10 days post-operative	No
Secondary	To compare the incidence of post-operative hemorrhage in subjects receiving celecoxib versus placebo		operative and 10 days post-operative	Yes
Secondary	To compare the number of days of leave from work or school that subjects need in the postoperative period in subjects receiving celecoxib versus placebo		3 weeks post-operatively	No