Dipyrone Versus Acetaminophen in the Control of Postoperative Pain

February 8, 2013 updated by: Thallita Pereira Queiroz, University Center of Araraquara
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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%

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain control with analgesics drugs
Time Frame: forty-eight hours
forty-eight hours

Secondary Outcome Measures

Outcome Measure
Time Frame
visual analog scale
Time Frame: forty-eight hours
forty-eight hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Center of Araraquara

Collaborators

University of Sao Paulo

Investigators

  • Principal Investigator: Thallita P Queiroz, MSc, São Paulo State University - UNESP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • upeclin/FOA-Unesp-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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