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Trial registered on ANZCTR


Registration number
ACTRN12618000969268
Ethics application status
Approved
Date submitted
5/06/2018
Date registered
8/06/2018
Date last updated
8/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Perioperative Single-Dose Oral Pregabalin and Intravenous Ibuprofen Combination Administration for Postoperative Pain After Third Molar Surgery
Scientific title
Comparisons the effects of preventive intravenous ibuprofen infusion and the combinations of intravenous ibuprofen infusion together with 2 different single oral dose of pregabalin on the postoperative pain after mandibular third molar extractions under local anesthesia
Secondary ID [1] 295083 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
impacted third molar 308206 0
perioperative analgesia 308207 0
Condition category
Condition code
Anaesthesiology 307200 307200 0 0
Pain management
Oral and Gastrointestinal 307202 307202 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-Dose Oral Pregabalin and Intravenous Ibuprofen Combination Administration before oral surgery. The treatment groups included the following: (Group 1) premedicated with oral placebo and intravenous (IV) placebo, (Group 2) premedicated with oral placebo and 400 mg IV Ibuprofen, (Group 3) premedicated with 75 mg oral pregabalin and 400 mg IV ibuprofen, and (Group 4) premedicated with 150 mg oral pregabalin and 400 mg IV ibuprofen.
Oral pregabalin (75 or 150 mg) (Lyrica; Pfizer, Inc., New York, NY) and oral placebo (using similar looking cornstarch capsules) were administered to the corresponding treatment groups one hour before surgery. Intravenous ibuprofen (400 mg) (Intrafen; Gen Pharmaceuticals, Istanbul, Turkey) and intravenous placebo (sterile saline solution) were administered via intravenous infusion 30 minutes before surgery

The medications were administered by a nurse who supervised by the director of the department, from the oral and maxillofacial surgery department.
Intervention code [1] 301429 0
Treatment: Drugs
Comparator / control treatment
(Group 1) premedicated with oral placebo (using similar looking cornstarch capsules) and intravenous (IV) placebo (sterile saline solution) ,
Control group
Placebo

Outcomes
Primary outcome [1] 306150 0
The primary outcome measured was postoperative pain levels;
All subjects were instructed to rate the severity of their pain using a horizontal, plain 100-mm length visual analog scale (VAS) with anchors of “no pain” on one side and “worst pain imaginable” on the other.
Timepoint [1] 306150 0
Postoperative pain was assessed every hour for the first 12 hours following surgery. Pain was then assessed at 8, 12, 16, and 20 h during the second and third days and at 12 h during the fourth, fifth and sixth postoperative days.

Patients were instructed to record their pain on VAS in the mentioned time intervals
Secondary outcome [1] 347799 0
the nonnarcotic analgesic requirement ( number of nonnarcotic analgesic tablets required by patients during postoperative 6 days) We recorded the time when the surgery finished and
patients has a postoperative logbook .The patients recorded the time of first analgesic request after surgery and the number of tablets consumed. After 6 days we collected all logbooks and calculated the data .
Timepoint [1] 347799 0
6 days post commencement of intervention
Secondary outcome [2] 347800 0
the first rescue analgesic request time (The duration of first analgesic need after surgery)
We recorded the time when the surgery finished and patients has a postoperative logbook .The patients recorded the time of first analgesic request after surgery and the number of tablets consumed. After 6 days we collected all logbooks and calculated the data .
Timepoint [2] 347800 0
During first 24 hour after the end of intervention

Eligibility
Key inclusion criteria
presence of soft tissue-impacted third molars, or partially or fully bony impacted mandibular third molars in a Pell-Gregory class II-B position that required surgical removal
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patient refusal, age outside of 18-24 years, ASA scores of III or IV, renal or hepatic failure, allergy to the study medication or related drugs, immune compromised status, psychological disorders, bleeding disorders, gastrointestinal system complaints, epilepsy or other neurological disorders, pregnancy or those breastfeeding, medication use less than 10 days before the surgery, preoperative inflammation, and lactose intolerance. Patients whose impacted teeth were exposed to the oral cavity before surgery and those, in which the duration of the surgical procedure exceeded 30 minutes, were also excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were assigned to one of the four treatment arms using randomized computer-generated numbers (generated in www. randomizer. org). Ninety opaque coded envelopes bearing serial numbers for the four treatment arms were prepared. A nurse, who was not part of the study, prepared the envelopes and performed the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
paralel multi armed study
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
IBM SPSS Statistics Standard Grad Pack version 22.0 for Windows (IBM Corporation, Armonk, NY licensed from Ataturk University, Erzurum, Turkey) was used for the statistical analyses. The normality of the quantitative data distribution was evaluated using the Shapiro-Wilk test. Kruskal-Wallis tests were used to compare the four groups in terms of the duration of the surgical procedure, surgical difficulty, intensity of the postoperative pain (VAS scores) at different time intervals, analgesic consumption, and first rescue analgesic request time after surgery. The demographic data and complications related to the medications were analyzed using Chi-square' tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
30/12/2016
Date of last data collection
Anticipated
Actual
28/02/2017
Sample size
Target
76
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 10529 0
Turkey
State/province [1] 10529 0
erzurum

Funding & Sponsors
Funding source category [1] 299701 0
Self funded/Unfunded
Name [1] 299701 0
Alpin Degirmenci
Country [1] 299701 0
Turkey
Funding source category [2] 299702 0
University
Name [2] 299702 0
Atatürk University
Country [2] 299702 0
Turkey
Primary sponsor type
University
Name
Ataturk University
Address
University District,Atatürk University ,25030, Yakutiye/ Erzurum, Turkey
Country
Turkey
Secondary sponsor category [1] 298993 0
None
Name [1] 298993 0
Address [1] 298993 0
Country [1] 298993 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300562 0
Ethical Review Board of Ataturk University Faculty of Dentistry
Ethics committee address [1] 300562 0
Ethics committee country [1] 300562 0
Turkey
Date submitted for ethics approval [1] 300562 0
Approval date [1] 300562 0
29/02/2016
Ethics approval number [1] 300562 0
3/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84074 0
Dr alpin degirmenci
Address 84074 0
Clinic of Oral Surgery, Çanakkale Oral And Dental Health Center,
Cumhuriyet District,Sahil Yolu Street,No :7,17100 City Center of Çanakkale
Country 84074 0
Turkey
Phone 84074 0
+905307866742
Fax 84074 0
Email 84074 0
alpn.dds@gmail.com
Contact person for public queries
Name 84075 0
alpin degirmenci
Address 84075 0
Clinic of Oral Surgery, Çanakkale Oral And Dental Health Center,
Cumhuriyet District,Sahil Yolu Street,No :7,17100 City Center of Çanakkale
Country 84075 0
Turkey
Phone 84075 0
+905307866742
Fax 84075 0
Email 84075 0
alpn.dds@gmail.com
Contact person for scientific queries
Name 84076 0
Ertan Yalçin
Address 84076 0
Assistant Professor, Department of Oral and Maxillofacial Surgery,Faculty of Dentistry
University District,Atatürk University ,25030, Yakutiye/ Erzurum, Turkey
Country 84076 0
Turkey
Phone 84076 0
+905422668735
Fax 84076 0
Email 84076 0
ertanyalcin2005@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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