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.
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.
Department of Biotechnologies and Medical Surgical Sciences, Sapienza University of Rome, Rome, Italy.
Maria Paola
0000-0001-7583-7030
MP
Cristalli
Department of Sense Organs, Sapienza University of Rome, Rome, Italy.
Gerardo
G
La Monaca
Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, Rome, Italy.
Chiara
C
De Angelis
Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, Rome, Italy.
Nicola
0000-0003-4095-0900
N
Pranno
Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, Rome, Italy.
Susanna
0000-0002-6631-7444
S
Annibali
D000082:Acetaminophen / Q000008:administration & dosage*; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage*; D003061:Codeine / Q000008:administration & dosage*; D015331:Cohort Studies; D004311:Double-Blind Method; D004333:Drug Administration Routes; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D063168:Mandibular Osteotomy / Q000009:adverse effects*; D008964:Molar, Third / Q000601:surgery*; D009407:Nerve Block / Q000379:methods; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology* / Q000517:prevention & control*; D055815:Young Adult
D000700:Analgesics; D004338:Drug Combinations; C526278:acetaminophen, codeine drug combination; D000082:Acetaminophen; D003061:Codeine