Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain
Condition: Surgery
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this placebo controlled clinical trial is to evaluate the dose response
      relationship of ibuprofen in doses from 400 mg to 800 mg and paracetamol (acetaminophen)in
      doses from 500 mg to 1000 mg compared with paracetamol (acetaminophen)1000 mg plus codeine 60
      mg on acute postoperative pain after surgical removal of impacted third molars.
    

Detailed description: 
      Acetaminophen (paracetamol) and related aspirin-like drugs have traditionally been used for
      pain control of minor to moderate postoperative pain. Gradually traditional non-steroidal
      anti-inflammatory drugs (NSAIDs) have become more popular as analgesics due to assumed
      superior therapeutic effects and aggressive marketing campaigns orchestrated by the
      pharmaceutical industry.

      Ibuprofen is a widely used analgesic both in non-prescription and prescription doses.

      A dose-response relationship for low ibuprofen doses is shown. Evidence of a progressing dose
      response relationship for moderate (i.e. 400 mg) to higher doses is scarce. A possible
      analgesic ceiling effect has been suggested for doses above 400 mg, although a correlation
      between given ibuprofen doses above 400 mg and patient serum levels is shown. However, it may
      be questioned if the plasma concentration of ibuprofen is an important determinator of
      analgesic drug efficacy. A higher dose is more likely to influence the duration of analgesic
      effect rather than the peak analgesic effect.

      There are few clinical trials investigating the dose-response relationship of increasing
      ibuprofen doses and paracetamol doses. To our knowledge no published study has investigated
      the dose-response relationship of ibuprofen and paracetamol in the same trial with a negative
      (i.e. placebo) and a positive (i.e. best standard analgesic treatment) control group.
    

Intervention name(s): Placebo; Ibuprofen 400 mg; Ibuprofen 600 mg; Ibuprofen 800 mg; Paracetamol (acetaminophen) 500 mg; Paracetamol (acetaminophen) 1000 mg; Paracetamol (acetaminophen) 1000 mg + codeine 60 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Lactose as powder in gelatine capsules, single dose; Ibuprofen 400 mg as powder in gelatine capsules, single dose; Ibuprofen 600 mg as powder in gelatine capsules, single dose; Ibuprofen 800 mg as powder in gelatine capsules, single dose; Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose; Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose; Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose
Other intervention name(s): Lactose; M01A E01 Ibuprofen; M01A E01 Ibuprofen; M01A E01 Ibuprofen; N02B E01 Paracetamol (acetaminophen); N02B E01 Paracetamol (acetaminophen); N02B E01 Paracetamol (acetaminophen) + R05D A04 codeine
Intervention MeSH terms: Acetaminophen; Ibuprofen; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Analgesics; Molar; Third; Acetaminophen; Paracetamol; Ibuprofen; Codeine; Placebo