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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).


Detailed Summary:
Sponsor: Nova Scotia Health Authority

Current Primary Outcome:

  • 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


Original Primary Outcome:

  • Mean daily and final VAS scores
  • Mean daily and final Likert scores
  • Total pain relief
  • Sum of pain intensity differences
  • Cumulative Weekly VAS scores.


Current Secondary Outcome:

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


Original Secondary Outcome:

  • Treatment failures
  • Amount of medication used
  • Days to stopping medication
  • Incidence of side effects
  • compliance with regime


Information By: Nova Scotia Health Authority

Dates:
Date Received: October 26, 2005
Date Started: January 2005
Date Completion:
Last Updated: March 28, 2008
Last Verified: March 2008