NCT03170726

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

May 20, 2017

Last Update Submit

May 26, 2017

Conditions

Preemptive Intravenous IbuprofenIntraoperative Analgesia

Keywords

Preemptive intravenous ibuprofenIntraoperative analgesiaThird molar tooth surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • postoperative pain as assessed by visual analogue scale

    5 month

Study Arms (3)

arveles

ACTIVE COMPARATOR

Ibuprofen 800 mg in normal saline 150 cc and dexketoprofen (50 mg) before operation will be given in 30 minutes

Drug: arvelesDrug: intrafen 800 mgOther: plasebos

intrafen

ACTIVE COMPARATOR

intrafen 800 mg in normal saline 150 cc before operation will be given in 30 minutes

Drug: arvelesDrug: intrafen 800 mgOther: plasebos

plasebos

PLACEBO COMPARATOR

150 cc normal saline will be given in 30 minutes during preoperative period

Drug: arvelesDrug: intrafen 800 mgOther: plasebos

Interventions

arvelesDRUG

Intraoperative and postoperative pain values between these three groups will be compared.

Also known as: dexketoprofen
arvelesintrafenplasebos
intrafen 800 mgDRUG

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.

Also known as: ibuprofen i.v.
arvelesintrafenplasebos
plasebosOTHER

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

arvelesintrafenplasebos

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan University

Erzincan, 24100, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 16725024BACKGROUND

  • 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.

    PMID: 19087009BACKGROUND

  • 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.

    PMID: 19222770BACKGROUND

  • 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.

    PMID: 12579384RESULT

  • 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.

    PMID: 19606021RESULT

MeSH Terms

Interventions

dexketoprofen trometamol

Study Officials

  • ilke kupeli

    Erzincan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assist. prof.

Study Record Dates

First Submitted

May 20, 2017

First Posted

May 31, 2017

Study Start

May 15, 2017

Primary Completion

October 30, 2017

Study Completion

November 15, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)