Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth
Primary Purpose
Preemptive Intravenous Ibuprofen, Intraoperative Analgesia
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
arveles
intrafen 800 mg
plasebos
Sponsored by
![Erzincan University](https://trials-media.s3.amazonaws.com/orgs/erzincan-university.jpeg)
About this trial
This is an interventional treatment trial for Preemptive Intravenous Ibuprofen focused on measuring Preemptive intravenous ibuprofen, Intraoperative analgesia, Third molar tooth surgery
Eligibility 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
Sites / Locations
- Erzincan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
arveles
intrafen
plasebos
Arm Description
Ibuprofen 800 mg in normal saline 150 cc and dexketoprofen (50 mg) before operation will be given in 30 minutes
intrafen 800 mg in normal saline 150 cc before operation will be given in 30 minutes
150 cc normal saline will be given in 30 minutes during preoperative period
Outcomes
Primary Outcome Measures
intraoperative pain as assessed by visual analogue scale
Assessment of Preemptive intravenous ibuprofen on intraoperative analgesic efficacy in 3. molar tooth extraction
Secondary Outcome Measures
postoperative pain as assessed by visual analogue scale
postoperative analgesic contribution of preemptively administered intravenous ibuprofen.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03170726
Brief Title
Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth
Official Title
Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Anticipated)
Study Completion Date
November 15, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzincan University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preemptive Intravenous Ibuprofen, Intraoperative Analgesia
Keywords
Preemptive intravenous ibuprofen, Intraoperative analgesia, Third molar tooth surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
arveles
Arm Type
Active Comparator
Arm Description
Ibuprofen 800 mg in normal saline 150 cc and dexketoprofen (50 mg) before operation will be given in 30 minutes
Arm Title
intrafen
Arm Type
Active Comparator
Arm Description
intrafen 800 mg in normal saline 150 cc before operation will be given in 30 minutes
Arm Title
plasebos
Arm Type
Placebo Comparator
Arm Description
150 cc normal saline will be given in 30 minutes during preoperative period
Intervention Type
Drug
Intervention Name(s)
arveles
Other Intervention Name(s)
dexketoprofen
Intervention Description
Intraoperative and postoperative pain values between these three groups will be compared.
Intervention Type
Drug
Intervention Name(s)
intrafen 800 mg
Other Intervention Name(s)
ibuprofen i.v.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
plasebos
Intervention Description
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 Measure Information:
Title
intraoperative pain as assessed by visual analogue scale
Description
Assessment of Preemptive intravenous ibuprofen on intraoperative analgesic efficacy in 3. molar tooth extraction
Time Frame
5 month
Secondary Outcome Measure Information:
Title
postoperative pain as assessed by visual analogue scale
Description
postoperative analgesic contribution of preemptively administered intravenous ibuprofen.
Time Frame
5 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ilke kupeli
Organizational Affiliation
Erzincan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erzincan University
City
Erzincan
ZIP/Postal Code
24100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16725024
Citation
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.
Results Reference
background
PubMed Identifier
19087009
Citation
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.
Results Reference
background
PubMed Identifier
19222770
Citation
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.
Results Reference
background
PubMed Identifier
12579384
Citation
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.
Results Reference
result
PubMed Identifier
19606021
Citation
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.
Results Reference
result
Learn more about this trial
Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth
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