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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT04730297

Collaborator

(none)

120

Enrollment

Location

Arms

33.4

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
To Control Pain After Third Molar Surgery	Drug: paracetamol 500 mg plus codeine 30 mg preoperative administration Drug: ibuprofen 400 mg preoperative administration Drug: Placebo oral tablet preoperative administration	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Sep 4, 2020

Actual Study Completion Date :

Oct 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) [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.

Secondary Outcome Measures

Number of patients requiring rescue therapy [until 12-hours after surgery and over extra two days]
outcomes involved the number of patients requiring rescue therapy
first postoperative use of analgesics [until 12-hours after surgery]
time of the first intake
total postoperative use of analgesics [until 12-hours after surgery and over extra two days]
total amount of additional medication

Other Outcome Measures

Compare the efficacy of the same drugs [up to 48 hours after stage 1]
Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 29 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maria Paola Cristalli	Roma		Italy	00100

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

Principal Investigator: Maria Paola Cristalli, DDS, PhD, Sapienza University of Rome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Paola Cristalli, Associate Professor DDS, PhD, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT04730297

Other Study ID Numbers:

2704/2013

First Posted:

Jan 29, 2021

Last Update Posted:

Jan 29, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maria Paola Cristalli, Associate Professor DDS, PhD, University of Roma La Sapienza

postsurgical dental pain

Additional relevant MeSH terms:

Acetaminophen

Ibuprofen

Codeine

Study Results

No Results Posted as of Jan 29, 2021