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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

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

20 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT03170726

First Posted

May 20, 2017

Last Updated

May 26, 2017

Sponsor

Erzincan University

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

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

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

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