To Control Pain After Third Molar Surgery
Conditions
Keywords
postoperative pain, paracetamol, codeine, tooth extractions, analgesia, premedication
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.
Interventions
preoperative administration
DRUGPlacebo Oral Tablet
preoperative administration
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
A randomized, split-mouth, placebo-controlled, double-blind clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. | All study participants were asked to record the pain intensity score at 1:00 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. | All study participants were asked to record the pain intensity score at 8:00 am 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. | All study participants were asked to record the pain intensity score at 8:00 am 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients using rescue therapy | Number of patients using rescue therapy on the same day from the end of the surgery and during 2 days after operative days | Number of patients using rescue therapy during 3 days after surgery |
| Time of analgesic medication | Time elapsed from the end of surgery until the first intake of analgesic medication on the same day of the surgery | Time elapsed from the end of surgery until the first intake of analgesic medication (minutes) |
| Number of paracetamol-codeine tablets | Number of paracetamol-codeine tablets taken by the patients during the 3 days after surgery | Total number of paracetamol-codeine tablets with the same formulation taken by the patient in relation to the pain symptoms |
Outcome results
None listed