NCT00921700

Brief Summary

The purpose of this study is to determine whether the combination of paracetamol (acetaminophen) and other NSAIDs with or without weak opioids can give synergistic analgesic effect.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

5.4 years

First QC Date

June 15, 2009

Last Update Submit

March 29, 2016

Conditions

Pain, Postoperative

Keywords

ParacetamolAcetaminophenIbuprofenPainPostoperative painthird molar

Outcome Measures

Primary Outcomes (1)

  • Sum pain intensity SPI (0-10 Numerical Rating Scale)

    6 hours

Secondary Outcomes (3)

  • Sum pain intensity difference score (PID)

    6 hours

  • Overall assessment of efficacy (4-point Verbal Rating Scale)

    6 hours

  • Adverse effects AE (Specific reporting of AE - type, duration and severity)

    6 hours

Study Arms (4)

Ibuprofen + Paracetamol

EXPERIMENTAL

Single oral dose of ibuprofen 400 mg + paracetamol (acetaminophen) 1000 mg

Drug: Ibuprofen + Paracetamol

Ibuprofen + Paracetamol + Codeine

EXPERIMENTAL

Single oral dose of ibuprofen 400 mg + paracetamol (acetaminophen) 1000 mg + codeine 60 mg

Drug: Ibuprofen + Paracetamol + Codeine

Paracetamol + Codeine

ACTIVE COMPARATOR

Single oral dose of paracetamol (acetaminophen) 1000 mg + codeine 60 mg

Drug: Paracetamol + Codeine

Placebo

PLACEBO COMPARATOR

Single oral dose of lactose as placebo

Drug: Placebo

Interventions

Ibuprofen + ParacetamolDRUG

Single oral dose of ibuprofen 400 mg combined with paracetamol (acetaminophen) 1000 mg in gelatine capsules

Also known as: Ibuprofen, ATC code: M01A E01, Paracetamol (Acetaminophen), ATC code: N02B E01
Ibuprofen + Paracetamol
Ibuprofen + Paracetamol + CodeineDRUG

Single oral dose of ibuprofen 400 mg combined with paracetamol (acetaminophen) 1000 mg and codeine 60 mg in gelatine capsules

Also known as: Ibuprofen, ATC code: M01A E01, Paracetamol (Acetaminophen), ATC code: N02B E01, Codeine, ATC code: R05D A04
Ibuprofen + Paracetamol + Codeine
Paracetamol + CodeineDRUG

Single oral dose of paracetamol (acetaminophen) 1000 mg combined with codeine 60 mg in gelatine capsules

Also known as: Paracetamol (Acetaminophen), ATC code: N02B E01, Codeine, ATC code: R05D A04
Paracetamol + Codeine
PlaceboDRUG

Single oral dose of lactose as placebo in gelatine capsules

Also known as: Lactose, CAS No: 63-42-3
Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of ASA class I in need of surgical removal of impacted third molars and with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars.

You may not qualify if:

  • Females stating not suspected or not verified pregnancy after being questioned by investigator.
  • Patients who have used analgesics for 3 days prior to the day of surgery.
  • Patients with known active gastrointestinal bleeding or ulcer.
  • Patients with any known hypersensitivity to NSAIDs.
  • Patients with other drug treatment than contraceptives.
  • Patients smoking before taking the test-drug or during the observation period.
  • Drug addicts or rehabilitated drug addicts.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, NO-0407, Norway

Location

Related Publications (7)

  • Seideman P. Additive effect of combined naproxen and paracetamol in rheumatoid arthritis. Br J Rheumatol. 1993 Dec;32(12):1077-82. doi: 10.1093/rheumatology/32.12.1077.

    PMID: 8252318BACKGROUND

  • Seideman P, Samuelson P, Neander G. Naproxen and paracetamol compared with naproxen only in coxarthrosis. Increased effect of the combination in 18 patients. Acta Orthop Scand. 1993 Jun;64(3):285-8. doi: 10.3109/17453679308993626.

    PMID: 8322582BACKGROUND

  • Breivik EK, Barkvoll P, Skovlund E. Combining diclofenac with acetaminophen or acetaminophen-codeine after oral surgery: a randomized, double-blind single-dose study. Clin Pharmacol Ther. 1999 Dec;66(6):625-35. doi: 10.1053/cp.1999.v66.103629001.

    PMID: 10613619BACKGROUND

  • Romsing J, Moiniche S, Dahl JB. Rectal and parenteral paracetamol, and paracetamol in combination with NSAIDs, for postoperative analgesia. Br J Anaesth. 2002 Feb;88(2):215-26. doi: 10.1093/bja/88.2.215.

    PMID: 11878655BACKGROUND

  • Hyllested M, Jones S, Pedersen JL, Kehlet H. Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. Br J Anaesth. 2002 Feb;88(2):199-214. doi: 10.1093/bja/88.2.199.

    PMID: 11878654BACKGROUND

  • Skoglund LA, Skjelbred P, Fyllingen G. Analgesic efficacy of acetaminophen 1000 mg, acetaminophen 2000 mg, and the combination of acetaminophen 1000 mg and codeine phosphate 60 mg versus placebo in acute postoperative pain. Pharmacotherapy. 1991;11(5):364-9.

    PMID: 1745622BACKGROUND

  • Lyngstad G, Skjelbred P, Swanson DM, Skoglund LA. Analgesic effect of oral paracetamol 1000 mg/ibuprofen 400 mg, paracetamol 1000 mg/codeine 60 mg, paracetamol 1000 mg/ibuprofen 400 mg/codeine 60 mg, or placebo on acute postoperative pain: a single-dose, randomized, and double-blind study. Eur J Clin Pharmacol. 2023 Aug;79(8):1131-1141. doi: 10.1007/s00228-023-03525-0. Epub 2023 Jun 22.

    PMID: 37349498DERIVED

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

IbuprofenAcetaminophenCodeineacetaminophen, codeine drug combinationLactose

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Lasse A Skoglund, DDS, DSci

    University of Oslo

    STUDY DIRECTOR

  • Gaute Lyngstad, DDS

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

June 1, 2009

Primary Completion

November 1, 2014

Study Completion

April 1, 2015

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

NO(1)