Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain

Surgery Clinical Trial

Official title:

Analgesic Effect of Ibuprofen 400, 600 and 800 mg, Paracetamol 500 and 1000 mg, and Paracetamol 1000 mg Plus 60 mg Codeine: Single-dose, Randomized, Placebo-controlled and Double-blind Study on Acute Pain After Third Molar Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699114
• Other study ID #: PARIBU-020
• Status: Completed
• Phase: Phase 4
• First received: June 12, 2008
• Last updated: July 3, 2011
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Patients of both sexes referred for surgical removal of impacted third molars, due to symptoms or after being advised to do so by their dentist.

• Persons of both sexes (ASA type I).

• Females who are not pregnant or plan conception.

• Persons who have not used analgesics for 3 days prior to the day of surgery.

• Persons without known active ulcus or gastrointestinal bleeding.

• Persons without any known hypersensitivity for NSAIDs.

• Persons under no other continuous drug treatment than contraceptives.

• Caucasian origin.

• Persons with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars.

Exclusion Criteria:

• Patients with surgery time exceeding 60 minutes

• Peroperative complications such as profuse bleeding or perforation to the maxillary sinus requiring additional drug treatment during or after the surgical removal of the third molar.

• Postoperative complications such as extended bleeding, nausea and regurgitation during the observation period.

• Smoking before taking the test-drug or during the observation period.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Surgery

Intervention

Drug:
• Placebo
Lactose as powder in gelatine capsules, single dose
• Ibuprofen 400 mg
Ibuprofen 400 mg as powder in gelatine capsules, single dose
• Ibuprofen 600 mg
Ibuprofen 600 mg as powder in gelatine capsules, single dose
• Ibuprofen 800 mg
Ibuprofen 800 mg as powder in gelatine capsules, single dose
• Paracetamol (acetaminophen) 500 mg
Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose
• Paracetamol (acetaminophen) 1000 mg
Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose
• Paracetamol (acetaminophen) 1000 mg + codeine 60 mg
Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose

Locations

Country	Name	City	State
Norway	Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum Pain Intensity Score(SPI)		3 hour observation period	No
Secondary	Sum Pain Intensity Difference Score (SPID)		3 hours	No
Secondary	Sum Pain Intensity Score (SPI)		6 hours	No
Secondary	Sum Pain Intensity Difference Score (SPID)		6 hours	No
Secondary	Maximum Pain Intensity Difference Score (MAXPID)		Unknown, calculated variable	No
Secondary	Time to Maximum Pain Intensity Difference Score		Unknown, calculated variable	No
Secondary	Self-reported Occurrence of Adverse Effects		3 hours	Yes
Secondary	Self-reported Occurrence of Adverse Effects		6 hours	Yes