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

NCT ID: NCT04730297

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-10-14

Brief Summary

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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.

Detailed Description

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Materials and methods: One hundred twenty healthy outpatients aged 15 to 29 years undergoing surgical removal of one bony impacted mandibular third molar were enrolled in this, single-center, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial. Study participants were randomly assigned to three treatment arms. According to the concealed allocation, each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg (group A), ibuprofen 400 mg (group B) or placebo (group C). Rescue therapy allowed in the postoperative period was paracetamol 500 mg plus codeine 30 mg in groups A and C and ibuprofen 400 mg in group B. Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity, total number of postoperative-supplement medications and time of the first intake, until 12-hours after surgery and over extra two days

Conditions

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To Control Pain After Third Molar Surgery

Keywords

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postsurgical dental pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a single-center, 2-stage, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Paracetamol/codeine Group A

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

Group Type ACTIVE_COMPARATOR

paracetamol 500 mg plus codeine 30 mg preoperative administration

Intervention Type DRUG

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

Ibuprofen Group B

analgesic group preoperative oral dose of ibuprofen 400 mg

Group Type ACTIVE_COMPARATOR

ibuprofen 400 mg preoperative administration

Intervention Type DRUG

each patient 30 minutes before surgery received ibuprofen 400 mg

Placebo Group C

Placebo group preoperative placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet preoperative administration

Intervention Type DRUG

each patient 30 minutes before surgery received placebo

Interventions

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paracetamol 500 mg plus codeine 30 mg preoperative administration

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

Intervention Type DRUG

ibuprofen 400 mg preoperative administration

each patient 30 minutes before surgery received ibuprofen 400 mg

Intervention Type DRUG

Placebo oral tablet preoperative administration

each patient 30 minutes before surgery received placebo

Intervention Type DRUG

Other Intervention Names

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GROUP A GROUP B GROUP C

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Maria Paola Cristalli

Associate Professor DDS, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Paola Cristalli, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

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Maria Paola Cristalli

Roma, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 34922726 (View on PubMed)

Other Identifiers

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2704/2013

Identifier Type: -

Identifier Source: org_study_id