Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery
- Conditions
- To Control Pain After Third Molar Surgery
- Interventions
- Drug: Placebo oral tablet preoperative administration
- Registration Number
- NCT04730297
- Lead Sponsor
- University of Roma La Sapienza
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paracetamol/codeine Group A paracetamol 500 mg plus codeine 30 mg preoperative administration analgesic group preoperative oral dose of paracetamol 500 mg plus codeine 30 mg Ibuprofen Group B ibuprofen 400 mg preoperative administration analgesic group preoperative oral dose of ibuprofen 400 mg Placebo Group C Placebo oral tablet preoperative administration Placebo group preoperative placebo
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Maria Paola Cristalli
🇮🇹Roma, Italy