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

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.

Conditions

• Surgery

Interventions

DRUG

Placebo

Lactose as powder in gelatine capsules, single dose

DRUG

Ibuprofen 400 mg

Ibuprofen 400 mg as powder in gelatine capsules, single dose

DRUG

Ibuprofen 600 mg

Ibuprofen 600 mg as powder in gelatine capsules, single dose

DRUG

Ibuprofen 800 mg

Ibuprofen 800 mg as powder in gelatine capsules, single dose

DRUG

Paracetamol (acetaminophen) 500 mg

Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose

DRUG

Paracetamol (acetaminophen) 1000 mg

Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose

DRUG

Paracetamol (acetaminophen) 1000 mg + codeine 60 mg

Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose

Sponsors & Collaborators

• University of Oslo

  collaborator OTHER

• Ullevaal University Hospital

  lead OTHER

Principal Investigators

• Lasse A Skoglund, DDS, DSCi · Section of Dental Pharmacology and Pharmacotherapy, ICD, Faculty of Dentistry, University of Oslo, POB 1119 Blindern, N-0317 Oslo, Norway

• Per Skjelbred, MD, DDS, PhD · Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital, Kirkeveien 166, N-0407 Oslo, Norway

• Gaute Lyngstad, DDS · Section of Dental Pharmacology and Pharmacotherapy, ICD, Faculty of Dentistry, University of Oslo, POB 1119 Blindern, N0317 Oslo, Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2009-12-31

Completion

2009-12-31

Countries

• Norway

Study Locations