NCT04730297

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 15 Years – 29 Years
• Healthy volunteers: Accepted

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

Conditions

• To Control Pain After Third Molar Surgery

Interventions

Type	Name	Description
DRUG	paracetamol 500 mg plus codeine 30 mg preoperative administration	each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg
DRUG	ibuprofen 400 mg preoperative administration	each patient 30 minutes before surgery received ibuprofen 400 mg
DRUG	Placebo oral tablet preoperative administration	each patient 30 minutes before surgery received placebo

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-09-04
• Completion: 2020-10-14
• First posted: 2021-01-29
• Last updated: 2021-01-29

Locations

1 site across 1 country: Italy