Dipyrone Versus Acetaminophen in the Control of Postoperative Pain

This study has been completed.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Thallita Pereira Queiroz, University Center of Araraquara
ClinicalTrials.gov Identifier:
NCT00841841
First received: February 10, 2009
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Drug: dipyrone and acetaminophen
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dipyrone Versus Acetaminophen in the Control of Postoperative Pain

Resource links provided by NLM:


Further study details as provided by University Center of Araraquara:

Primary Outcome Measures:
  • Pain control with analgesics drugs [ Time Frame: forty-eight hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • visual analog scale [ Time Frame: forty-eight hours ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dipyrone

Analgesic affectiveness using Dipyrone (500mg) as a postoperative drug for pain relief.

Intervention: "Drug: dipyrone and acetaminophen"

Drug: dipyrone and acetaminophen
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 Names:
  • Dipyrone: Novalgina
  • Acetaminophen: Tylenol
Experimental: Acetaminophen

Analgesic affectiveness using Acetaminophen (750mg) as a postoperative drug for pain relief.

Intervention: "Drug: dipyrone and acetaminophen"

Drug: dipyrone and acetaminophen
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 Names:
  • Dipyrone: Novalgina
  • Acetaminophen: Tylenol

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%

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • good general health

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841841

Sponsors and Collaborators
University Center of Araraquara
University of Sao Paulo
Investigators
Principal Investigator: Thallita P Queiroz, MSc São Paulo State University - UNESP
  More Information

No publications provided

Responsible Party: Thallita Pereira Queiroz, Thallita Pereira Queiroz, DDS, MSc, PhD, University Center of Araraquara
ClinicalTrials.gov Identifier: NCT00841841     History of Changes
Other Study ID Numbers: upeclin/FOA-Unesp-02
Study First Received: February 10, 2009
Last Updated: February 8, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University Center of Araraquara:
Analgesia
molar third
acetaminophen
dipyrone

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Dipyrone
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014