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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single dose placebo capsule |
|
| Ibuprofen 400 mg | Active Comparator | Single dose ibuprofen 400 mg capsule |
|
| Ibuprofen 600 mg | Active Comparator | Single dose ibuprofen 600 mg capsule |
|
| Ibuprofen 800 mg | Active Comparator | Single dose ibuprofen 800 mg capsule |
|
| Paracetamol 500 mg | Active Comparator | Paracetamol 500 mg (acetaminophen) capsule |
|
| Paracetamol 1000 mg | Active Comparator | Single dose paracetamol 1000 mg (acetaminophen) capsule |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Lactose as powder in gelatine capsules, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum Pain Intensity Score(SPI) | 3 hour observation period |
| Measure | Description | Time Frame |
|---|---|---|
| Sum Pain Intensity Difference Score (SPID) | 3 hours | |
| Sum Pain Intensity Score (SPI) | 6 hours | |
| Sum Pain Intensity Difference Score (SPID) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Per Skjelbred, MD, DDS, PhD | Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital, Kirkeveien 166, N-0407 Oslo, Norway | Study Director |
| Gaute Lyngstad, DDS | Section of Dental Pharmacology and Pharmacotherapy, ICD, Faculty of Dentistry, University of Oslo, POB 1119 Blindern, N0317 Oslo, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital | Oslo | N-0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34655316 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 4, 2022 | |
| Reset | Mar 7, 2022 |
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| Paracetamol 1000 mg + codeine 60 mg | Active Comparator | Single dose paracetamol (acetaminophen) 1000 mg + codeine 60 mg capsule |
|
| Ibuprofen 400 mg | Drug | Ibuprofen 400 mg as powder in gelatine capsules, single dose |
|
|
| Ibuprofen 600 mg | Drug | Ibuprofen 600 mg as powder in gelatine capsules, single dose |
|
|
| Ibuprofen 800 mg | Drug | Ibuprofen 800 mg as powder in gelatine capsules, single dose |
|
|
| Paracetamol (acetaminophen) 500 mg | Drug | Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose |
|
|
| Paracetamol (acetaminophen) 1000 mg | Drug | Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose |
|
|
| Paracetamol (acetaminophen) 1000 mg + codeine 60 mg | Drug | Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose |
|
|
| 6 hours |
| Maximum Pain Intensity Difference Score (MAXPID) | Unknown, calculated variable |
| Time to Maximum Pain Intensity Difference Score | Unknown, calculated variable |
| Self-reported Occurrence of Adverse Effects | 3 hours |
| Self-reported Occurrence of Adverse Effects | 6 hours |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 4, 2022 | Mar 7, 2022 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007785 | Lactose |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| D003061 | Codeine |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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