A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery
Information source: Capital District Health Authority, Canada
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Laparoscopic Cholecystectomy; Inguinal Hernia; Abdominal Hernia; Umbilical Hernia
Intervention: Tylenol #3 (Drug); Combination Tylenol and Ibuprofen (Drug)
Sponsored by: Capital District Health Authority, Canada
Official(s) and/or principal investigator(s):
Geoffrey A Porter, MD, FRCSC, Study Director, Affiliation: CDHA/Dalhousie University
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
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.
Official title: A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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
Amount of medication used
Days to stopping medication
Incidence of side effects
Compliance with regimen
Minimum age: 17 Years.
Maximum age: 65 Years.
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.
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.
Locations and Contacts
Dartmouth General Hospital, Dartmouth, Nova Scotia B2Y 4G8, Canada
Starting date: January 2005
Ending date: December 2005
Last updated: March 28, 2008