Clinical Study
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
Maria Paola Cristalli,
1
Gerardo La Monaca,
2
Chiara De Angelis,
3
Nicola Pranno,
3
and Susanna Annibali
3
1
Department of Biotechnologies and Medical Surgical Sciences, Sapienza University of Rome, Rome, Italy
2
Department of Sense Organs, Sapienza University of Rome, Rome, Italy
3
Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, Rome, Italy
Correspondence should be addressed to Maria Paola Cristalli; mariapaola.cristalli@uniroma1.it
Received 29 November 2016; Revised 11 January 2017; Accepted 17 January 2017; Published 23 February 2017
Academic Editor: Alessandro Villa
Copyright © 2017 Maria Paola Cristalli et al. Tis is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited.
Objectives. Te aim of this study was to determine the efectiveness of preoperative administration of single-dose of paracetamol-
codeine, in the relieving of acute postoperative pain afer the surgical removal of an impacted mandibular third molar. Materials
and Methods. Te 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 frst and second surgeries. Study participants were asked to record pain intensity scores during
the operation and the next 2 days, the time of the frst request for rescue analgesic, and the total number of postoperative-supplement
paracetamol-codeine tablets. Results. Te pain intensity score on the frst day was signifcantly lower in the analgesic group than in
the placebo group ( < 0.001). Te time to using rescue therapy was signifcantly longer in the analgesic group than in the placebo
group ( = 0.004). Te number of paracetamol-codeine tablets used postoperatively did not difer between the analgesic and
placebo groups ( = 0.104). Conclusions. Preoperative paracetamol-codeine is efective in providing immediate postoperative pain
control afer third molar surgery and in delaying the initial onset of pain. Tis trial is registered with ClinicalTrials.gov Identifer
(Registration Number): NCT03049878.
1. Introduction
Te removal of impacted mandibular third molars is nowa-
days one of the most frequent oral surgical procedures.
Nevertheless, postsurgical complications such as acute post-
operative pain, swelling, bruising, and limited mouth open-
ing occur frequently, and these have an immediate negative
impact on the working and social lives of patients [1, 2].
Te postoperative pain is undoubtedly the most unpleasant
symptom for the patient and, despite receiving analgesic
therapy, may persist even 1 week afer the surgery, leading
to increased morbidity and negatively infuencing the well-
being and quality of life [3–5].
Various analgesic combinations have been proposed for
minimizing this complication. Combining diferent phar-
macologic classes of analgesic drugs that have diferent
mechanisms of action and side-efect profles, resulting in
additive or synergic efects, may improve the efcacy of pain
therapy [6]. In addition, the use of the individual drugs at
lower doses in such combinations is associated with a lower
incidence of adverse efects [7, 8].
Furthermore, a single tablet containing two diferent
analgesics at fxed doses seems to provide better relief of
acute postoperative pain than the individual administration
of the same drugs as separate tablets [9]. Tere are many
reports in the literature of the efectiveness of combined
Hindawi
Pain Research and Management
Volume 2017, Article ID 9246352, 6 pages
https://doi.org/10.1155/2017/9246352