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
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Analgesia, molar third, acetaminophen, dipyrone
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.
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
NCT ID
NCT00841841
First Posted
February 10, 2009
Last Updated
February 8, 2013
Sponsor
University Center of Araraquara
Collaborators
University of Sao Paulo
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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Dipyrone Versus Acetaminophen in the Control of Postoperative Pain
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