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Dipyrone Versus Acetaminophen in the Control of Postoperative Pain

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
dipyrone and acetaminophen
Sponsored by
University Center of Araraquara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Analgesia, molar third, acetaminophen, dipyrone

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Dipyrone

    Acetaminophen

    Arm Description

    Analgesic affectiveness using Dipyrone (500mg) as a postoperative drug for pain relief. Intervention: "Drug: dipyrone and acetaminophen"

    Analgesic affectiveness using Acetaminophen (750mg) as a postoperative drug for pain relief. Intervention: "Drug: dipyrone and acetaminophen"

    Outcomes

    Primary Outcome Measures

    Pain control with analgesics drugs

    Secondary Outcome Measures

    visual analog scale

    Full Information

    First Posted
    February 10, 2009
    Last Updated
    February 8, 2013
    Sponsor
    University Center of Araraquara
    Collaborators
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00841841
    Brief Title
    Dipyrone Versus Acetaminophen in the Control of Postoperative Pain
    Official Title
    Dipyrone Versus Acetaminophen in the Control of Postoperative Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Center of Araraquara
    Collaborators
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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%

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    Analgesia, molar third, acetaminophen, dipyrone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dipyrone
    Arm Type
    Experimental
    Arm Description
    Analgesic affectiveness using Dipyrone (500mg) as a postoperative drug for pain relief. Intervention: "Drug: dipyrone and acetaminophen"
    Arm Title
    Acetaminophen
    Arm Type
    Experimental
    Arm Description
    Analgesic affectiveness using Acetaminophen (750mg) as a postoperative drug for pain relief. Intervention: "Drug: dipyrone and acetaminophen"
    Intervention Type
    Drug
    Intervention Name(s)
    dipyrone and acetaminophen
    Other Intervention Name(s)
    Dipyrone: Novalgina, Acetaminophen: Tylenol
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Pain control with analgesics drugs
    Time Frame
    forty-eight hours
    Secondary Outcome Measure Information:
    Title
    visual analog scale
    Time Frame
    forty-eight hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thallita P Queiroz, MSc
    Organizational Affiliation
    São Paulo State University - UNESP
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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