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

This study has been completed.
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00245375
First received: October 26, 2005
Last updated: March 28, 2008
Last verified: March 2008
  Purpose

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 require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen.

Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument.

The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day).

This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free.

The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.


Condition Intervention
Laparoscopic Cholecystectomy
Inguinal Hernia
Abdominal Hernia
Umbilical Hernia
Drug: Tylenol #3
Drug: Combination Tylenol and Ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Mean daily and final visual analog scale (VAS) scores
  • Mean daily and final Likert scores
  • Total pain relief
  • Sum of pain intensity differences
  • Cumulative weekly VAS scores

Secondary Outcome Measures:
  • Treatment failures
  • Amount of medication used
  • Days to stopping medication
  • Incidence of side effects
  • Compliance with regimen

Estimated Enrollment: 150
Study Start Date: January 2005
Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245375

Locations
Canada, Nova Scotia
Dartmouth General Hospital
Dartmouth, Nova Scotia, Canada, B2Y 4G8
Sponsors and Collaborators
Capital District Health Authority, Canada
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Study Director: Geoffrey A Porter, MD, FRCSC CDHA/Dalhousie University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00245375     History of Changes
Other Study ID Numbers: CDHA003
Study First Received: October 26, 2005
Last Updated: March 28, 2008
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Outpatient Surgery for:
inguinal hernia repair
abdominal hernia repair
umbilical hernia repair

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Umbilical
Hernia, Abdominal
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014