None listed
Conditions
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
Interventions
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
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.
Sponsors
María Cristina Vallecillo Rivas
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Volunteer patients of the Master of Oral Surgery and Implantology demanding an extraction of a third lower molar
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.
Outcome results
None listed