Clinical trial NCT03049878: Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: To Control Pain After Third Molar Surgery
Keywords: postoperative pain
paracetamol
codeine
tooth extractions
analgesia
premedication
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, split-mouth, placebo-controlled, double-blind clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
timeFrame: All study participants were asked to record the pain intensity score at 1:00 pm during the operative day
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
timeFrame: All study participants were asked to record the pain intensity score at 6:00 pm during the operative day
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
timeFrame: All study participants were asked to record the pain intensity score at 11:00 pm during the operative day
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
timeFrame: All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
timeFrame: All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
timeFrame: All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
timeFrame: All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
timeFrame: All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
timeFrame: All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
timeFrame: All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
timeFrame: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery
Secondary outcomes:
Other outcomes:
measure: Number of patients using rescue therapy
timeFrame: Number of patients using rescue therapy on the same day from the end of the surgery and during 2 days after operative days
measure: Time of analgesic medication
timeFrame: Time elapsed from the end of surgery until the first intake of analgesic medication on the same day of the surgery
measure: Number of paracetamol-codeine tablets
timeFrame: Number of paracetamol-codeine tablets taken by the patients during the 3 days after surgery
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Maria Paola Cristalli, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cristalli MP, La Monaca G, De Angelis C, Pranno N, Annibali S. Efficacy of Preoperative Administration of Paracetamol-Codeine on Pain following Impacted Mandibular Third Molar Surgery: A Randomized, Split-Mouth, Placebo-Controlled, Double-Blind Clinical Trial. Pain Res Manag. 2017;2017:9246352. doi: 10.1155/2017/9246352. Epub 2017 Feb 23.