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, Gerardo La Monaca, Chiara De Angelis, Nicola Pranno, Susanna Annibali, Maria Paola Cristalli, Gerardo La Monaca, Chiara De Angelis, Nicola Pranno, Susanna Annibali

Abstract

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 postoperative 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. Results. The pain intensity score on the first day was significantly lower in the analgesic group than in the placebo group (p < 0.001). The time to using rescue therapy was significantly longer in the analgesic group than in the placebo group (p = 0.004). The number of paracetamol-codeine tablets used postoperatively did not differ between the analgesic and placebo groups (p = 0.104). Conclusions. Preoperative paracetamol-codeine is effective in providing immediate postoperative pain control after third molar surgery and in delaying the initial onset of pain. This trial is registered with ClinicalTrials.gov Identifier (Registration Number): NCT03049878.

Conflict of interest statement

The authors declare that there is no conflict of interests regarding the publication of this paper.

Figures

Figure 1
Figure 1
Pain intensity score (NRS-11) in the placebo and analgesic groups recorded at specific time intervals on the three days after surgery. Data are expressed as the mean and SD values. Significant difference in the NRS-11 score between the two groups was found only in the first day after surgery (p < 0.001).
Figure 2
Figure 2
Box-and-whisker plots related to the pain scores (NRS-11) in patients which received the placebo or analgesic drug, respectively, in the first or second surgery. The dark line in the middle of the boxes is the median. The box represents the interquartile (IQ) range which contains the middle 50% of the records. The whiskers are lines that extend from the upper and lower edge of the box to the highest and lowest values which are no greater than 1.5 times the IQ range. The circles are outliers. These are defined as values that do not fall in the whiskers. The asterisks or stars are extreme outliers. These represent cases that have values more than three times the height of the boxes.

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Source: PubMed

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