Dipyrone Versus Acetaminophen in the Control of Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Adequate postoperative pain management is challenging for practitioners despite recent
      advances in pain control techniques and analgesic agents. The purpose of this study is to
      compare the efficacy of Dipyrone and acetaminophen in postoperative pain after third molar
      surgery.
    

Detailed description: 
      Thirty patients scheduled for surgical removal of impacted third molars at the Discipline of
      Oral and Maxillofacial Surgery and Traumatology of the Dental School of Araçatuba, São Paulo
      State University, Brazil, were selected for the study after review and approval of the
      research protocol by the institutional Research Ethics Committee (Protocol #2006-01083). All
      patients received verbal and written explanations about the study purposes and procedures,
      and all of them signed an informed consent form prior to enrollment.

      Patients should be in good general health and those who fulfilled any of the following
      criteria were excluded: systemic disorders; known hypersensitivity to any of the study
      medications; pregnancy or nursing; local contraindication to surgery as judged by the oral
      surgeon; and use of any analgesic agent 24 hours before surgery.

      All patients were premedicated with oral dexamethasone 4 mg one hour before surgery for
      modulation of the postoperative edema. The surgical procedures were performed by a single
      operator according to a standardized surgical protocol and in compliance with all principles
      of the surgical technique. All patients received standard verbal and written postoperative
      instructions regarding diet, oral hygiene and general care.

      The patients were randomly assigned to 2 groups of 15 patients, according to the drug
      prescribed as postoperative medication: Group I: dipyrone 500 mg every 6 hours (4 males, 11
      females, mean age = 25.2 years) and Group II: paracetamol 750 mg every 6 hours (3 males, 12
      females, mean age = 26.8 years). Amoxicillin 500 mg was prescribed for all patients. All
      surgeries were completed within 1 hour and were performed under local anesthesia with
      injection of an average volume of 3.6 mL of 2% mepivacaine with 1:100,000 adrenaline per
      surgical site. No relevant perioperative complications were observed.

      In Group I, 3 maxillary right third molars, 9 maxillary left third molars, 10 mandibular left
      third molars and 9 mandibular right third molars were extracted. The following impaction
      positions were observed: vertical (n=22), horizontal (n=4) and medio-angulated (n=4). During
      surgery, osteotomy was necessary in 2 surgical sites and osteotomy associated with tooth
      sectioning was required in 8 cases. In Group II, 1 maxillary right third molar, 9 maxillary
      left third molars, 12 mandibular left third molar and 3 mandibular right third molars were
      extracted. The following impaction positions were observed: vertical (n=18), horizontal (n=2)
      and medio-angulated (n=3). During surgery, osteotomy, tooth sectioning and osteotomy
      associated with tooth sectioning were performed in 6, 3 and 6 cases, respectively.

      Pain intensity was rated by the patients using a 4-point visual analog scale (VAS): 0 (no
      pain), 1 (mild pain), 2 (moderate pain), 3 (severe pain), 4 (unendurable pain). Measurements
      of pain intensity were performed in the immediate postoperative period and every 6 hours
      after surgery until completing 48 hours. Reports on the relief of the different pain
      intensities were obtained from the patients at the pre-established intervals (6 hours) using
      an ordinal scale in order to obtain the mean pain intensity scores for each patient and for
      each group. The use of a nonparametric statistical test was thus required for data
      comparison. Mann-Whitney test was used to compare the study groups by analyzing the mean pain
      intensity scores obtained every 6 hours, in the first 24 hours, in the final 24 hours and in
      the total 48-hour period. Significance level was set at 5%
    

Intervention name(s): dipyrone and acetaminophen
Intervention type(s): Drug
Intervention description(s): The patients were randomly assigned to 2 groups of 15 patients, according to the drug prescribed as postoperative medication: Group I: dipyrone 500 mg every 6 hours (4 males, 11 females, mean age = 25.2 years) and Group II: paracetamol 750 mg every 6 hours (3 males, 12 females, mean age = 26.8 years)
Other intervention name(s): Dipyrone: Novalgina; Acetaminophen: Tylenol
Intervention MeSH terms: Acetaminophen; Dipyrone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Analgesia; molar third; acetaminophen; dipyrone