SurgeryPhase 4NCT00699114
Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain
A Phase 4 study testing Ibuprofen 400 mg, Ibuprofen 600 mg and Ibuprofen 800 mg in people with Surgery, run by Ullevaal University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Ibuprofen 400 mg, Ibuprofen 600 mg and Ibuprofen 800 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Oslo, N-0407
About this study
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
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Placebo, Ibuprofen 400 mg, Ibuprofen 600 mg, Ibuprofen 800 mg, Paracetamol (acetaminophen) 500 mg
- Keywords
- Pain, Analgesics, Molar, Third, Acetaminophen, Paracetamol, Ibuprofen, Codeine, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Lactose
Lactose as powder in gelatine capsules, single dose
Ibuprofen 400 mgDrug
Also called M01A E01 Ibuprofen
Ibuprofen 400 mg as powder in gelatine capsules, single dose
Ibuprofen 600 mgDrug
Also called M01A E01 Ibuprofen
Ibuprofen 600 mg as powder in gelatine capsules, single dose
Ibuprofen 800 mgDrug
Also called M01A E01 Ibuprofen
Ibuprofen 800 mg as powder in gelatine capsules, single dose
Paracetamol (acetaminophen) 500 mgDrug
Also called N02B E01 Paracetamol (acetaminophen)
Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose
Paracetamol (acetaminophen) 1000 mgDrug
Also called N02B E01 Paracetamol (acetaminophen)
Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose
Paracetamol (acetaminophen) 1000 mg + codeine 60 mgDrug
Also called N02B E01 Paracetamol (acetaminophen) + R05D A04 codeine
Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single dose placebo capsule Receives: Drug: Placebo |
| Ibuprofen 400 mg | Active comparator | Single dose ibuprofen 400 mg capsule Receives: Drug: Ibuprofen 400 mg |
| Ibuprofen 600 mg | Active comparator | Single dose ibuprofen 600 mg capsule Receives: Drug: Ibuprofen 600 mg |
| Ibuprofen 800 mg | Active comparator | Single dose ibuprofen 800 mg capsule Receives: Drug: Ibuprofen 800 mg |
| Paracetamol 500 mg | Active comparator | Paracetamol 500 mg (acetaminophen) capsule Receives: Drug: Paracetamol (acetaminophen) 500 mg |
| Paracetamol 1000 mg | Active comparator | Single dose paracetamol 1000 mg (acetaminophen) capsule Receives: Drug: Paracetamol (acetaminophen) 1000 mg |
| Paracetamol 1000 mg + codeine 60 mg | Active comparator | Single dose paracetamol (acetaminophen) 1000 mg + codeine 60 mg capsule Receives: Drug: Paracetamol (acetaminophen) 1000 mg + codeine 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum Pain Intensity Score(SPI)
Measured: 3 hour observation period
Secondary outcomes (7)
Sum Pain Intensity Difference Score (SPID)
Measured: 3 hours
Sum Pain Intensity Score (SPI)
Measured: 6 hours
Sum Pain Intensity Difference Score (SPID)
Measured: 6 hours
Maximum Pain Intensity Difference Score (MAXPID)
Measured: Unknown, calculated variable
Time to Maximum Pain Intensity Difference Score
Measured: Unknown, calculated variable
Self-reported Occurrence of Adverse Effects
Measured: 3 hours
Self-reported Occurrence of Adverse Effects
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Lasse A Skoglund, DDS, DSCi, Study chair, Section of Dental Pharmacology and Pharmacotherapy, ICD, Faculty of Dentistry, University of Oslo, POB 1119 Blindern, N-0317 Oslo, NorwayPer Skjelbred, MD, DDS, PhD, Study director, Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital, Kirkeveien 166, N-0407 Oslo, NorwayGaute Lyngstad, DDS, Principal investigator, Section of Dental Pharmacology and Pharmacotherapy, ICD, Faculty of Dentistry, University of Oslo, POB 1119 Blindern, N0317 Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699114
- Sponsor's protocol ID
- PARIBU-020
- Status last verified
- Feb 2009
- First submitted
- 12 Jun 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34655316
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00699114
- Acronym / sponsor ID
- PARIBU-020
- Conditions
- Surgery
- Keywords
- Pain, Analgesics, Molar, Third, Acetaminophen, Paracetamol, Ibuprofen, Codeine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSingle dose placebo capsule |
| Ibuprofen 400 mg | Active comparator | Drug: Ibuprofen 400 mgSingle dose ibuprofen 400 mg capsule |
| Ibuprofen 600 mg | Active comparator | Drug: Ibuprofen 600 mgSingle dose ibuprofen 600 mg capsule |
| Ibuprofen 800 mg | Active comparator | Drug: Ibuprofen 800 mgSingle dose ibuprofen 800 mg capsule |
| Paracetamol 500 mg | Active comparator | Drug: Paracetamol (acetaminophen) 500 mgParacetamol 500 mg (acetaminophen) capsule |
| Paracetamol 1000 mg | Active comparator | Drug: Paracetamol (acetaminophen) 1000 mgSingle dose paracetamol 1000 mg (acetaminophen) capsule |
| Paracetamol 1000 mg + codeine 60 mg | Active comparator | Drug: Paracetamol (acetaminophen) 1000 mg + codeine 60 mgSingle dose paracetamol (acetaminophen) 1000 mg + codeine 60 mg capsule |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: LactoseLactose as powder in gelatine capsules, single dose | Drug | Placebo |
| Ibuprofen 400 mgAlso: M01A E01 IbuprofenIbuprofen 400 mg as powder in gelatine capsules, single dose | Drug | Ibuprofen 400 mg |
| Ibuprofen 600 mgAlso: M01A E01 IbuprofenIbuprofen 600 mg as powder in gelatine capsules, single dose | Drug | Ibuprofen 600 mg |
| Ibuprofen 800 mgAlso: M01A E01 IbuprofenIbuprofen 800 mg as powder in gelatine capsules, single dose | Drug | Ibuprofen 800 mg |
| Paracetamol (acetaminophen) 500 mgAlso: N02B E01 Paracetamol (acetaminophen)Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose | Drug | Paracetamol 500 mg |
| Paracetamol (acetaminophen) 1000 mgAlso: N02B E01 Paracetamol (acetaminophen)Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose | Drug | Paracetamol 1000 mg |
| Paracetamol (acetaminophen) 1000 mg + codeine 60 mgAlso: N02B E01 Paracetamol (acetaminophen) + R05D A04 codeineParacetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose | Drug | Paracetamol 1000 mg + codeine 60 mg |
Primary outcome
Sum Pain Intensity Score(SPI)
Time frame: 3 hour observation period
7 secondary outcomes
Sum Pain Intensity Difference Score (SPID)
Time frame: 3 hours
Sum Pain Intensity Score (SPI)
Time frame: 6 hours
Sum Pain Intensity Difference Score (SPID)
Time frame: 6 hours
Maximum Pain Intensity Difference Score (MAXPID)
Time frame: Unknown, calculated variable
Time to Maximum Pain Intensity Difference Score
Time frame: Unknown, calculated variable
Self-reported Occurrence of Adverse Effects
Time frame: 3 hours
Self-reported Occurrence of Adverse Effects
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
- Derived from this study: PubMed 34655316Lyngstad 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lasse A Skoglund, DDS, DSCi 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 study director
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital, Kirkeveien 166, N-0407 Oslo, Norway
Gaute Lyngstad, DDS principal investigator
Section of Dental Pharmacology and Pharmacotherapy, ICD, Faculty of Dentistry, University of Oslo, POB 1119 Blindern, N0317 Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen 400 mg, Ibuprofen 600 mg and Ibuprofen 800 mg in people with Surgery, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum Pain Intensity Score(SPI) (time frame: 3 hour observation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.