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Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth

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ClinicalTrials.gov Identifier: NCT03170726
Recruitment Status : Unknown
Verified May 2017 by ILKE KUPELI, Erzincan University.
Recruitment status was:  Active, not recruiting
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
ILKE KUPELI, Erzincan University

Brief Summary:
This study was planned to evaluate the analgesic efficacy of preemptive intravenous (iv) ibuprofen on pain occurring during and after the mandibular third molar surgeon

Condition or disease Intervention/treatment Phase
Preemptive Intravenous Ibuprofen Intraoperative Analgesia Drug: arveles Drug: intrafen 800 mg Other: plasebos Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : November 15, 2017


Arm Intervention/treatment
Active Comparator: arveles
Ibuprofen 800 mg in normal saline 150 cc and dexketoprofen (50 mg) before operation will be given in 30 minutes
Drug: arveles
Intraoperative and postoperative pain values between these three groups will be compared.
Other Name: dexketoprofen

Drug: intrafen 800 mg
ibuprofen 800 mg in normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.
Other Name: ibuprofen i.v.

Other: plasebos
normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.

Active Comparator: intrafen
intrafen 800 mg in normal saline 150 cc before operation will be given in 30 minutes
Drug: arveles
Intraoperative and postoperative pain values between these three groups will be compared.
Other Name: dexketoprofen

Drug: intrafen 800 mg
ibuprofen 800 mg in normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.
Other Name: ibuprofen i.v.

Other: plasebos
normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.

Placebo Comparator: plasebos
150 cc normal saline will be given in 30 minutes during preoperative period
Drug: arveles
Intraoperative and postoperative pain values between these three groups will be compared.
Other Name: dexketoprofen

Drug: intrafen 800 mg
ibuprofen 800 mg in normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.
Other Name: ibuprofen i.v.

Other: plasebos
normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.




Primary Outcome Measures :
  1. intraoperative pain as assessed by visual analogue scale [ Time Frame: 5 month ]
    Assessment of Preemptive intravenous ibuprofen on intraoperative analgesic efficacy in 3. molar tooth extraction


Secondary Outcome Measures :
  1. postoperative pain as assessed by visual analogue scale [ Time Frame: 5 month ]
    postoperative analgesic contribution of preemptively administered intravenous ibuprofen.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are to be elected third molar tooth extraction
  • Patients between the ages of 20-35
  • Patients who are symptomatic
  • Third molar tooth angular or horizontal settled patients

Exclusion Criteria:

  • Patients who refuse to participate in the study
  • Patients under 20 years old, over 35 years old
  • Patients who are allergic to known non-steroidal anti-inflammatory drugs
  • Pregnant patients
  • Patients with severe liver failure,
  • patients with severe renal insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170726


Locations
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Turkey
Erzincan University
Erzincan, Turkey, 24100
Sponsors and Collaborators
Erzincan University
Investigators
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Principal Investigator: ilke kupeli Erzincan University

Publications of Results:
Other Publications:
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Responsible Party: ILKE KUPELI, assist. prof., Erzincan University
ClinicalTrials.gov Identifier: NCT03170726     History of Changes
Other Study ID Numbers: ERZINCAN UNIVERSITY 9
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ILKE KUPELI, Erzincan University:
Preemptive intravenous ibuprofen
Intraoperative analgesia
Third molar tooth surgery
Additional relevant MeSH terms:
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Ibuprofen
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexketoprofen trometamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action