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Effect of Celecoxib on Transitional Pain After Outpatient Surgery

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664690
First Posted: April 23, 2008
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawson Health Research Institute
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Celecoxib on Transitional Pain After Outpatient Surgery

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • visual analogue score for pain [ Time Frame: post-op period ]

Secondary Outcome Measures:
  • severity of nausea [ Time Frame: post-op period ]

Enrollment: 0
Arms Assigned Interventions
Experimental: 1
celebrex
Drug: celebrex
400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop
Placebo Comparator: 2
placebo
Drug: placebo
placebo given preop and BID postop

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664690


Locations
Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Ngozi Imasogie, MD Lawson Health Research Institute
  More Information

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00664690     History of Changes
Other Study ID Numbers: R-04-309
10457
First Submitted: April 18, 2008
First Posted: April 23, 2008
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Lawson Health Research Institute:
shoulder surgery
analgesia

Additional relevant MeSH terms:
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents