Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain
NCT ID: NCT00699114
Last Updated: 2011-07-06
Study Results
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Basic Information
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COMPLETED
PHASE4
350 participants
INTERVENTIONAL
2007-06-30
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Single dose placebo capsule
Placebo
Lactose as powder in gelatine capsules, single dose
Ibuprofen 400 mg
Single dose ibuprofen 400 mg capsule
Ibuprofen 400 mg
Ibuprofen 400 mg as powder in gelatine capsules, single dose
Ibuprofen 600 mg
Single dose ibuprofen 600 mg capsule
Ibuprofen 600 mg
Ibuprofen 600 mg as powder in gelatine capsules, single dose
Ibuprofen 800 mg
Single dose ibuprofen 800 mg capsule
Ibuprofen 800 mg
Ibuprofen 800 mg as powder in gelatine capsules, single dose
Paracetamol 500 mg
Paracetamol 500 mg (acetaminophen) capsule
Paracetamol (acetaminophen) 500 mg
Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose
Paracetamol 1000 mg
Single dose paracetamol 1000 mg (acetaminophen) capsule
Paracetamol (acetaminophen) 1000 mg
Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose
Paracetamol 1000 mg + codeine 60 mg
Single dose paracetamol (acetaminophen) 1000 mg + codeine 60 mg capsule
Paracetamol (acetaminophen) 1000 mg + codeine 60 mg
Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
30 Years
ALL
Yes
Sponsors
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University of Oslo
OTHER
Ullevaal University Hospital
OTHER
Responsible Party
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University of Oslo
Principal Investigators
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Lasse A Skoglund, DDS, DSCi
Role: STUDY_CHAIR
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
Role: STUDY_DIRECTOR
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital, Kirkeveien 166, N-0407 Oslo, Norway
Gaute Lyngstad, DDS
Role: PRINCIPAL_INVESTIGATOR
Section of Dental Pharmacology and Pharmacotherapy, ICD, Faculty of Dentistry, University of Oslo, POB 1119 Blindern, N0317 Oslo, Norway
Locations
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Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Oslo, , Norway
Countries
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References
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Lyngstad G, Skjelbred P, Swanson DM, Skoglund LA. Analgesic effect of oral ibuprofen 400, 600, and 800 mg; paracetamol 500 and 1000 mg; and paracetamol 1000 mg plus 60 mg codeine in acute postoperative pain: a single-dose, randomized, placebo-controlled, and double-blind study. Eur J Clin Pharmacol. 2021 Dec;77(12):1843-1852. doi: 10.1007/s00228-021-03231-9. Epub 2021 Oct 16.
Other Identifiers
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PARIBU-020
Identifier Type: -
Identifier Source: org_study_id
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