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

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

Study Overview

• Status: Unknown
• Conditions: Preemptive Intravenous Ibuprofen; Intraoperative Analgesia
• Intervention / Treatment: Drug: arveles; Drug: intrafen 800 mg; Other: plasebos

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzincan, Turkey, 24100
    • Erzincan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative pain as assessed by visual analogue scale	Assessment of Preemptive intravenous ibuprofen on intraoperative analgesic efficacy in 3. molar tooth extraction	5 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain as assessed by visual analogue scale	postoperative analgesic contribution of preemptively administered intravenous ibuprofen.	5 month

Collaborators and Investigators

• Sponsor: Erzincan University

Publications and helpful links

General Publications

• Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.
• Jerjes W, El-Maaytah M, Swinson B, Banu B, Upile T, D'Sa S, Al-Khawalde M, Chaib B, Hopper C. Experience versus complication rate in third molar surgery. Head Face Med. 2006 May 25;2:14. doi: 10.1186/1746-160X-2-14.
• Oscier CD, Milner QJ. Peri-operative use of paracetamol. Anaesthesia. 2009 Jan;64(1):65-72. doi: 10.1111/j.1365-2044.2008.05674.x.
• Hariharan S, Moseley H, Kumar A, Raju S. The effect of preemptive analgesia in postoperative pain relief--a prospective double-blind randomized study. Pain Med. 2009 Jan;10(1):49-53. doi: 10.1111/j.1526-4637.2008.00547.x.
• Trampitsch E, Pipam W, Moertl M, Sadjak A, Dorn C, Sittl R, Likar R. [Preemptive randomized, double-blind study with lornoxicam in gynecological surgery]. Schmerz. 2003 Jan;17(1):4-10. doi: 10.1007/s00482-001-0129-7. German.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Anticipated): October 30, 2017
• Study Completion (Anticipated): November 15, 2017

Study Registration Dates

• First Submitted: May 20, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Preemptive intravenous ibuprofen; Intraoperative analgesia; Third molar tooth surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen; Dexketoprofen trometamol
• Other Study ID Numbers: ERZINCAN UNIVERSITY 9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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