Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery

NCT04730297 | Completed Phase 4 DMC

• 1 other identifier: 2704/2013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To compare analgesic effects of preoperative administration of paracetamol 500 milligram plus codeine 30 milligram in single-tablet and effervescent formulation to ibuprofen 400 milligram, and placebo in the management of moderate to severe postoperative pain after mandibular third molar surgery.

Conditions

To Control Pain After Third Molar Surgery

Keywords

postsurgical dental pain

Outcome Measures

Primary Outcomes (11)

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to misure the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")

  All study participants were asked to record the pain intensity score at 1:00 pm during the operative day]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  All study participants were asked to record the pain intensity score at 6:00 pm during the operative day]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  All study participants were asked to record the pain intensity score at 11:00 pm during the operative day]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo

  All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo

  All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo

  All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery]

• Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

  In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery]

Secondary Outcomes (3)

• Number of patients requiring rescue therapy

  until 12-hours after surgery and over extra two days

• first postoperative use of analgesics

  until 12-hours after surgery

• total postoperative use of analgesics

  until 12-hours after surgery and over extra two days

Other Outcomes (1)

• Compare the efficacy of the same drugs

  up to 48 hours after stage 1

Study Arms (3)

Paracetamol/codeine Group A

ACTIVE COMPARATOR

analgesic group preoperative oral dose of paracetamol 500 mg plus codeine 30 mg

Drug: paracetamol 500 mg plus codeine 30 mg preoperative administration

Ibuprofen Group B

ACTIVE COMPARATOR

analgesic group preoperative oral dose of ibuprofen 400 mg

Drug: ibuprofen 400 mg preoperative administration

Placebo Group C

PLACEBO COMPARATOR

Placebo group preoperative placebo

Drug: Placebo oral tablet preoperative administration

Interventions

paracetamol 500 mg plus codeine 30 mg preoperative administration DRUG

each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg

Also known as: GROUP A

Paracetamol/codeine Group A

ibuprofen 400 mg preoperative administration DRUG

each patient 30 minutes before surgery received ibuprofen 400 mg

Also known as: GROUP B

Ibuprofen Group B

Placebo oral tablet preoperative administration DRUG

each patient 30 minutes before surgery received placebo

Also known as: GROUP C

Placebo Group C

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• healthy status (ASA class I);
• nonsmoker;
• not pregnant or breastfeeding;
• no medication consumption in the past 21 days;
• good oral hygiene;
• bony impaction of one mandibular third molars;
• the presence of the first and second molars;
• compliance to cooperate with the research protocol.

You may not qualify if:

• chronic systemic disease;
• medications with potential interaction to paracetamol-codeine or ibuprofen;
• a history of intolerance or hypersensitivity to the study drugs;
• any pre-existing pain and acute inflammatory or infectious conditions; - inability to understand or perform the study procedure.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Maria Paola Cristalli

Roma, 00100, Italy

Location

Related Publications (1)

• La Monaca G, Pranno N, Annibali S, Polimeni A, Pompa G, Vozza I, Cristalli MP. COMPARATIVE ANALGESIC EFFECTS OF SINGLE-DOSE PREOPERATIVE ADMINISTRATION OF PARACETAMOL (ACETAMINOPHEN) 500 mg PLUS CODEINE 30 mg AND IBUPROFEN 400 mg ON PAIN AFTER THIRD MOLAR SURGERY. J Evid Based Dent Pract. 2021 Dec;21(4):101611. doi: 10.1016/j.jebdp.2021.101611. Epub 2021 Jul 10.

  PMID: 34922726 DERIVED

MeSH Terms

Interventions

Acetaminophen; Codeine; Ibuprofen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Maria Paola Cristalli, DDS, PhD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor DDS, PhD

Model Details: a single-center, 2-stage, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 29, 2021
• Study Start: January 1, 2018
• Primary Completion: September 4, 2020
• Study Completion: October 14, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)