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

Study Overview
=================
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.

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

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

Conditions
-----------------
To Control Pain After Third Molar Surgery

Intervention / Treatment
-----------------
* Drug: paracetamol 500 mg plus codeine 30 mg preoperative administration
* Drug: ibuprofen 400 mg preoperative administration
* Drug: Placebo oral tablet preoperative administration


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a single-center, 2-stage, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol/codeine Group A<br>analgesic group preoperative oral dose of paracetamol 500 mg plus codeine 30 mg | Drug: paracetamol 500 mg plus codeine 30 mg preoperative administration<br>* each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg<br>* Other names: GROUP A;|
| Active Comparator: Ibuprofen Group B<br>analgesic group preoperative oral dose of ibuprofen 400 mg | Drug: ibuprofen 400 mg preoperative administration<br>* each patient 30 minutes before surgery received ibuprofen 400 mg<br>* Other names: GROUP B;|
| Placebo Comparator: Placebo Group C<br>Placebo group preoperative placebo | Drug: Placebo oral tablet preoperative administration<br>* each patient 30 minutes before surgery received placebo<br>* Other names: GROUP C;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients requiring rescue therapy | 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 of the first intake | until 12-hours after surgery | 
| total postoperative use of analgesics | total amount of additional medication | until 12-hours after surgery and over extra two days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postsurgical dental pain