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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 15 Years to 29 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Paracetamol/codeine Group A
analgesic group preoperative oral dose of paracetamol 500 mg plus codeine 30 mg
Intervention: paracetamol 500 mg plus codeine 30 mg preoperative administration (Drug)
Ibuprofen Group B
analgesic group preoperative oral dose of ibuprofen 400 mg
Intervention: ibuprofen 400 mg preoperative administration (Drug)
Placebo Group C
Placebo group preoperative placebo
Intervention: Placebo oral tablet preoperative administration (Drug)
Outcomes
Primary Outcomes
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time Frame: 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 Outcomes
- Number of patients requiring rescue therapy(until 12-hours after surgery and over extra two days)
- first postoperative use of analgesics(until 12-hours after surgery)
- total postoperative use of analgesics(until 12-hours after surgery and over extra two days)
Investigators
Maria Paola Cristalli
Associate Professor DDS, PhD
University of Roma La Sapienza