Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery: a Randomized, Split-mouth, Placebo-controller, Double-blind Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Primary Endpoint
- Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
Study Overview
Brief Summary
Objectives:
The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar.
Materials and Methods:
The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •absence of systemic pathologies (ASA class I);
- •non-smoker;
- •not pregnant or lactating;
- •good oral hygiene;
- •no drug consumption for 10 days before the operation;
- •bilateral impacted mandibular third molars with comparable position, depth and inclination;
- •presence of the first and second molars;
- •absence of painful symptoms and associated inflammatory or osteolytic pathologies in a radiographic examination;
- •extraction difficulty index of >7 according to Pederson's scale and a degree of IV (complex procedures) on a modified version of Parant's scale.
Exclusion Criteria
- Not provided
Arms & Interventions
analgesic group
preoperative oral dose of paracetamol-codeine
Intervention: Paracetamol Codeine (Drug)
placebo group
preoperative placebo (starch)
Intervention: Placebo Oral Tablet (Drug)
Outcomes
Primary Outcomes
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
Time Frame: All study participants were asked to record the pain intensity score at 11:00 pm during the operative day
The primary outcome of the study was the post-operative pain. 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")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
Time Frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery
The primary outcome of the study was the post-operative pain. 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")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
Time Frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery
The primary outcome of the study was the post-operative pain. 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")
Secondary Outcomes
No secondary outcomes reported
Investigators
Maria Paola Cristalli
DDS PhD, Clinical Professor
University of Roma La Sapienza