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

January 25, 2021 updated by: Maria Paola Cristalli, University of Roma La Sapienza

Comparative Analgesic Effects of Preoperative Administration of Paracetamol (Acetominophen) 500 mg Plus Codeine 30 mg and Ibuprofen 400 mg on Pain After Third Molar Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00100
        • Maria Paola Cristalli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 29 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Paracetamol/codeine Group A
analgesic group preoperative oral dose of paracetamol 500 mg plus codeine 30 mg
Drug: paracetamol 500 mg plus codeine 30 mg preoperative administration
each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg
Other Names:
  • GROUP A
ACTIVE_COMPARATOR: Ibuprofen Group B
analgesic group preoperative oral dose of ibuprofen 400 mg
Drug: ibuprofen 400 mg preoperative administration
each patient 30 minutes before surgery received ibuprofen 400 mg
Other Names:
  • GROUP B
PLACEBO_COMPARATOR: Placebo Group C
Placebo group preoperative placebo
Drug: Placebo oral tablet preoperative administration
each patient 30 minutes before surgery received placebo
Other Names:
  • GROUP C

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time Frame: All study participants were asked to record the pain intensity score at 1:00 pm during the operative day]
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)
Time Frame: All study participants were asked to record the pain intensity score at 6:00 pm during the operative day]

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)
Time Frame: All study participants were asked to record the pain intensity score at 11:00 pm during the operative day]
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)
Time Frame: All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery]
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)
Time Frame: All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery]
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)
Time Frame: All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery]
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)
Time Frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery]
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)
Time Frame: All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery]
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)
Time Frame: All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery]
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)
Time Frame: All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery]
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)
Time Frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery]
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients requiring rescue therapy
Time Frame: until 12-hours after surgery and over extra two days
outcomes involved the number of patients requiring rescue therapy
until 12-hours after surgery and over extra two days
first postoperative use of analgesics
Time Frame: until 12-hours after surgery
time of the first intake
until 12-hours after surgery
total postoperative use of analgesics
Time Frame: until 12-hours after surgery and over extra two days
total amount of additional medication
until 12-hours after surgery and over extra two days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare the efficacy of the same drugs
Time Frame: up to 48 hours after stage 1
Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity
up to 48 hours after stage 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Roma La Sapienza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Paola Cristalli, DDS, PhD, University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2704/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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