Dipyrone Versus Acetaminophen in the Control of Postoperative Pain

NCT00841841 | Completed Phase 2 DMC

• 1 other identifier: upeclin/FOA-Unesp-02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative

Keywords

Analgesia; molar third; acetaminophen; dipyrone

Outcome Measures

Primary Outcomes (1)

• Pain control with analgesics drugs

  forty-eight hours

Secondary Outcomes (1)

• visual analog scale

  forty-eight hours

Study Arms (2)

Dipyrone

EXPERIMENTAL

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

Drug: dipyrone and acetaminophen

Acetaminophen

EXPERIMENTAL

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

Drug: dipyrone and acetaminophen

Interventions

dipyrone and acetaminophen DRUG

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)

Also known as: Dipyrone: Novalgina, Acetaminophen: Tylenol

Acetaminophen; Dipyrone

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• good general health

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Center of Araraquara: lead
• University of Sao Paulo: collaborator

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Dipyrone; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Thallita P Queiroz, MSc

  São Paulo State University - UNESP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thallita Pereira Queiroz, DDS, MSc, PhD

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 11, 2009
• Study Start: March 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 12, 2013

Record last verified: 2013-02