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

NCT ID: NCT00245375

Last Updated: 2008-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-12-31

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 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.

Conditions

Laparoscopic Cholecystectomy; Inguinal Hernia; Abdominal Hernia; Umbilical Hernia

Keywords

Outpatient Surgery for: inguinal hernia repair; abdominal hernia repair; umbilical hernia repair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Tylenol #3

Intervention Type: DRUG

Combination Tylenol and Ibuprofen

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Principal Investigators

Geoffrey A Porter, MD, FRCSC

Role: STUDY_DIRECTOR

CDHA/Dalhousie University

Locations

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

Countries

Canada

Other Identifiers

CDHA003

Identifier Type: -

Identifier Source: org_study_id