Effect of Celecoxib on Transitional Pain After Outpatient Surgery

This study is currently recruiting participants.

Verified by Lawson Health Research Institute, April 2008

First Received: April 18, 2008 Last Updated: April 22, 2008 History of Changes

Sponsor:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00664690

Purpose

Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex started preoperatively and continued for 3 days. Rescue medications required as well as pain scores will be assessed using a patient diary to evaluate the effect of celebrex in controlling transitional pain

Condition	Intervention	Phase
Pain	Drug: celebrex Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Celecoxib on Transitional Pain After Outpatient Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

visual analogue score for pain [ Time Frame: post-op period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

severity of nausea [ Time Frame: post-op period ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2004
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental celebrex	Drug: celebrex 400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop
2: Placebo Comparator placebo	Drug: placebo placebo given preop and BID postop

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled for elective ambulatory surgery of the shoulder
ASA I - III
Able to read English
Male or female

Exclusion Criteria:

Allergy to local anesthetic, Cox2, sulpha drug, acetaminophen or oxycodone
Women who are pregnant or lactating and women of childbearing age and not following acceptable contraceptive precautions
Any major medical or psychiatric problem
Those with a known history of narcotic dependence, abuse or chronic narcotic intake
Patients with known history of peptic ulcer or GI bleeding in the past, ulcers, congestive heart failure, angina or previous heart attack, coagulation problems, venous thrombosis, kidney or liver disease or strokes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664690

Contacts

Contact: Ngozi Imasogie, MD

519-646-6000 ext 64219

nimasog@uwo.ca

Locations

Canada, Ontario
St. Joseph's Health Care	Recruiting
London, Ontario, Canada, N
Principal Investigator: Ngozi Imasogie, MD

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Principal Investigator:

Ngozi Imasogie, MD

Lawson Health Research Institute

More Information

No publications provided

Responsible Party:	Lawson Health Research Institute ( Dr. Ngozi Imasogie )
Study ID Numbers:	R-04-309, 10457
Study First Received:	April 18, 2008
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00664690 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

shoulder surgery
analgesia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010