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

To Control Pain After Third Molar Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730297
• Other study ID #: 2704/2013
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: October 14, 2020

Study information

• Verified date: January 2021
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 14, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• To Control Pain After Third Molar Surgery

Intervention

Drug:
• paracetamol 500 mg plus codeine 30 mg preoperative administration
each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg
• ibuprofen 400 mg preoperative administration
each patient 30 minutes before surgery received ibuprofen 400 mg
• Placebo oral tablet preoperative administration
each patient 30 minutes before surgery received placebo

Locations

Country	Name	City	State
Italy	Maria Paola Cristalli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the efficacy of the same drugs	Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity	up to 48 hours after stage 1
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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	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
Secondary	first postoperative use of analgesics	time of the first intake	until 12-hours after surgery
Secondary	total postoperative use of analgesics	total amount of additional medication	until 12-hours after surgery and over extra two days