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

University of Roma La Sapienza

Status and phase: Completed; Phase 4

Conditions: To Control Pain After Third Molar Surgery

Treatments: Drug: paracetamol 500 mg plus codeine 30 mg preoperative administration; Drug: ibuprofen 400 mg preoperative administration; Drug: Placebo oral tablet preoperative administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04730297

2704/2013

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 15 to 29 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

Paracetamol/codeine Group A

Active Comparator group

Description:

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

Treatment:

Drug: paracetamol 500 mg plus codeine 30 mg preoperative administration

Ibuprofen Group B

Active Comparator group

Description:

analgesic group preoperative oral dose of ibuprofen 400 mg

Treatment:

Drug: ibuprofen 400 mg preoperative administration

Placebo Group C

Placebo Comparator group

Description:

Placebo group preoperative placebo

Treatment:

Drug: Placebo oral tablet preoperative administration