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Trial registered on ANZCTR


Registration number
ACTRN12619001709134
Ethics application status
Approved
Date submitted
17/10/2019
Date registered
4/12/2019
Date last updated
4/12/2019
Date data sharing statement initially provided
4/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analgesic efficacy when extracting lower third molars
Scientific title
Analgesic effectiveness of Tramadol/dexketoprofen (TRAM/DKP) compared with Ibuprofen in the impacted third molar extraction pain model.
Secondary ID [1] 299581 0
None
Universal Trial Number (UTN)
U1111-1242-1978
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Third molar extraction 314858 0
Condition category
Condition code
Oral and Gastrointestinal 313196 313196 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
Assess the analgesic efficacy of Tramadol/dexketoprofen (TRAM/DKP) compared with Ibuprofen after the extraction of retained mandibular third molar. Patients will be divided into two groups based on a randomization table.
Group 1: it will be formed by thirty four patients. They will be given one tablet of Ibuprofen 400mg, 1 tablet every 8 hours during 48 h after extraction.
Group 2: it will be formed by thirty four patients. They will be given one tablet of Enanplus 75mg/25 mg (tramadol 75 mg/dexketoprofen 25 mg), 1 tablet every 8 hours during 48 h after extraction.

The extractions will be made by students of the Master of Oral Surgery and Implantology in the University of Granada.?Patients will be prescribed an antibiotic therapy consisting of amoxicillin 750 mg, 1 tablet every 8 hours for 6 days, for allergies to amoxicillin the antibiotic of choice will be clindamycin 300mg with the same regimen. Rescue medication consisted of 1g paracetamol if after 1 hour no effective analgesia was achieved with the given medication.

To ensure compliance with the study, patients are given a data collection sheet and an information paper. Patients will also be called by phone to ensure compliance with the study and in case of any doubt.
Intervention code [1] 315837 0
Treatment: Drugs
Comparator / control treatment
Ibuprofen 400mg each 8 hours during 48 h after extraction
Control group
Active

Outcomes
Primary outcome [1] 321707 0
Assess the analgesic efficacy of the combination of analgesics (tramadol hydrochloride 75mg / 25mg dexketoprofen), versus a single analgesic (ibuprofen 400mg), postoperative pain after third molar extraction of retained during the last 48 hours. Assessed using a Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS)
Timepoint [1] 321707 0
At 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after intervention
Secondary outcome [1] 375977 0
Difference of inflammation in the extraction area between groups, assessed using a Visual Analogue Scale (VAS) and a Verbal Rating Scale (VRS)
Timepoint [1] 375977 0
At 1, 2, 4, 6, 8, 12, 24, 36, 48 hours and 7 days after intervention.
Secondary outcome [2] 375978 0
Assess the percentage of patients who required rescue analgesics and number of tablets consumed.
To evaluate the percentage of patients who require rescue medication, a section will be included in the data collection sheet by the patient in which the patient must indicate if they have taken rescue medication (yes / no) and if so, the number of tablets (1/2/3 ..).
Timepoint [2] 375978 0
During 48 hours post intervention
Secondary outcome [3] 375979 0
Adverse effects of the given medication and intensity of this effects.
On the day of the suture removal, the principal investigator will ask the patient about the presence of adverse effects related to the medication (1. nausea, 2. vomiting, 3. somnolence, 4. dizziness, 5. tremors, 6. dyspepsia, 7. diarrhea, 8. bleeding and / or 9. disorientation) and its intensity (1. mild / 2. moderate / 3. severe).
Timepoint [3] 375979 0
During 48 hours post intervention

Eligibility
Key inclusion criteria
Volunteer patients of the Master of Oral Surgery and Implantology demanding an extraction of a third lower molar
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
It will be grounds for exclusion of the study, patients with:
- Pregnant or breastfeeding period.(for the risk of undergoing such an intervention and for the non-recommendation to take the medication used in the study during breastfeeding).
-Patients with some systemic pathology that may alter the results of the study or that the study medication may interfere with the patient's base medication.Only patients ASA I (classification of the American Society of Anesthesiology) will be included in the study. 
- Patients with known allergies to any of the study medications.
- Patients have taken antibiotics or analgesics 24 hours before the surgery.
- Pericoronitis days before surgery.

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)
Numbered containers with the treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample was determined with a confidence level of 95% and a power of 90%. A sample size was calculated to detect 2 points on the pain scale with a standard deviation of 2.5 based on previous studies, resulting in a sample size of 68 patients that will be divided into two groups using a randomization table. Statistical analysis will be carried out using the SPSS v 21.0 program (SPSS Inc., Chicago, IL). Analysis of qualitative variables will be carried out through frequency tables, contingency tables, along with bar graphs. Analysis of quantitative variables will be carried out through a statistical summary that includes coefficients of centralization and dispersion (arithmetic mean, median, standard deviation, minimum and maximum). The normality of variables will be verified by the Shapiro-Wilk test. The comparison between treatments for quantitative variables will be carried out using the Kruskall-Wallis or ANOVA test, and multiple comparisons between treatments using the Games-Howell test. In all the tests performed, the level of significance will be set at p = 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/10/2019
Date of last participant enrolment
Anticipated
20/12/2019
Actual
Date of last data collection
Anticipated
27/12/2019
Actual
Sample size
Target
68
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 21931 0
Spain
State/province [1] 21931 0
Granada

Funding & Sponsors
Funding source category [1] 304065 0
University
Name [1] 304065 0
Master of Oral Surgery and Implantology. Faculty of Dentistry, University of Granada
Country [1] 304065 0
Spain
Primary sponsor type
Individual
Name
María Cristina Vallecillo Rivas
Address
Colegio Máximo s/n. Campus Universitario de Cartuja. 18071. Granada, Spain
Country
Spain
Secondary sponsor category [1] 304261 0
None
Name [1] 304261 0
Address [1] 304261 0
Country [1] 304261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304556 0
Comité de ética en investigación de la Universidad de Granada
Ethics committee address [1] 304556 0
VICERECTORADO DE INVESTIGACION Y TRANSFERENCIA. Calle Gran Vía de Colon. Nº 48, 2 planta. 18071, Granada
Ethics committee country [1] 304556 0
Spain
Date submitted for ethics approval [1] 304556 0
17/01/2018
Approval date [1] 304556 0
01/02/2018
Ethics approval number [1] 304556 0
474/CEIH/2018

Summary
Brief summary
Clinical experience shows that, in the management of this type of pain of moderate-severe intensity, it is difficult to obtain effective analgesia with a single drug (monotherapy), and therefore combinations of analgesics are widely used to provide effective analgesia. (multimodal analgesia).
The main hypothesis from which we start is that patients who are given Enanplus 75mg / 25mg will have less pain intensity and will need less rescue medication than those taking ibuprofen and will not present any significant adverse effects
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97374 0
Miss María Cristina Vallecillo Rivas
Address 97374 0
Faculty of dentistry. Colegio Máximo, Campus Universitario de Cartuja C.P. 18071 (Granada). Spain
Country 97374 0
Spain
Phone 97374 0
+34690339494
Fax 97374 0
Email 97374 0
[email protected]
Contact person for public queries
Name 97375 0
María Cristina Vallecillo Rivas
Address 97375 0
Faculty of dentistry. Colegio Máximo, Campus Universitario de Cartuja C.P. 18071 (Granada). Spain
Country 97375 0
Spain
Phone 97375 0
+34690339494
Fax 97375 0
Email 97375 0
[email protected]
Contact person for scientific queries
Name 97376 0
María Cristina Vallecillo Rivas
Address 97376 0
Faculty of dentistry. Colegio Máximo, Campus Universitario de Cartuja C.P. 18071 (Granada). Spain
Country 97376 0
Spain
Phone 97376 0
+34690339494
Fax 97376 0
Email 97376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers that contact with principal investigator and who provide a methodologically sound proposal
Available for what types of analyses?
For IPD meta-analyses and systematic revisions
How or where can data be obtained?
Access subject to approvals by Principal Investigator when researchers contact with principal investigator by email, [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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