Status:

COMPLETED

A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery

Lead Sponsor:

Nova Scotia Health Authority

Collaborating Sponsors:

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Conditions:

Laparoscopic Cholecystectomy

Inguinal Hernia

Eligibility:

All Genders

17-65 years

Phase:

NA

Brief Summary

Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all r...

Eligibility Criteria

Inclusion

  • Patients may take part in this study if the answer is YES to all of these questions:
  • Female or male between 17-65 years of age
  • Going to have one of the following surgeries:
  • umbilical hernia repair
  • inguinal hernia repair
  • small incisional or abdominal wall hernia repair
  • laparoscopic cholecystectomy (gallbladder removed)
  • Going home after their surgery the same day
  • Have signed consent form.

Exclusion

  • Patients have had or have:
  • Been diagnosed with peptic ulcer disease or bleeding stomach ulcer in the recent past and are not currently on a proton pump inhibitor (special antacid medication, eg. Losec®, Pantoloc®, Prevacid®, Nexium®).
  • Suffered from asthma
  • Allergies to codeine, non-steroidal anti-inflammatory drugs (Advil®, Ibuprofen), aspirin, or acetaminophen
  • Been taking other prescription pain medications prior to their surgery
  • A history of chronic pain disorder
  • Fibromyalgia (a chronic pain illness with symptoms of muscle aches, pain, stiffness, general fatigue and sleep problems)
  • Active kidney disease or failure
  • Known liver disease
  • Are females who are pregnant or nursing
  • A problem with alcohol or drug abuse.

Key Trial Info

Start Date :

January 1 2005

Trial Type :

INTERVENTIONAL

End Date :

December 1 2005

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT00245375

Start Date

January 1 2005

End Date

December 1 2005

Last Update

April 1 2008

Active Locations (1)

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1

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada, B2Y 4G8