CLINICAL TRIAL TO EVALUATE THE EFFICACY OF IBUPROFEN COMBINED WITH DIFFERENT DOSES OF TRAMADOL AND TRAMADOL INTRAVENOUS AFTER DENTAL SURGERY

Phase 1

• Conditions: Moderate-Intense pain in Dental Surgery; MedDRA version: 20.0 Level: HLT Classification code 10044049 Term: Dental pain and sensation disorders System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2018-001412-30-ES
• Lead Sponsor: aboratorios Farmalíder S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-21
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

1. Patients who give their informed consent in writing and are willing to comply with all the visits and scheduled procedures required by the protocol.
2. Patients = 18 years.
3. Moderate-intense pain (SAV 0-100 =55 mm) during the first 4 hours after completing the surgery.
4. With body weight> 50 and <110 kg.
5. Scheduled for ambulatory surgical removal, under local anesthesia, of at least two third parties molars, at least one of them lower, and at least one of them impacted that requires elimination of bone.
6. That they agree not to take analgesics except for those that the protocol defines as medication of rescue during the treatment period, until after 7 hours after the administration of the study medication.
7. Have a medical history and physical examination without clinically relevant abnormalities in function of the study and at the discretion of the researcher
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with a history of allergy or hypersensitivity to the study medication, medication of rescue or any other non-steroidal anti-inflammatory drug (NSAID), opioids or acid acetylsalicylic, or any of its excipients.
2. History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or edema
angioneurotic.
3. History of peptic ulcer, gastrointestinal disorders due to NSAID, gastrointestinal hemorrhage or other active hemorrhages.
4. History of moderate to severe renal, hepatic or cardiac insufficiency.
5. Hemorrhagic diathesis or other coagulation disorders.
6. Epilepsy.
7. Crohn's disease or ulcerative colitis.
8. History of dependence on drugs of abuse or alcohol.
9. History of any disease or disorder that, in the opinion of the investigator, could constitute a risk to the patient or modify the results of the study (eg patients with acute pain of any other origin or location at the time of surgery).
10. Have had complications during the surgery, with duration greater than 1 hour and
that required re-anesthesia (after the appropriate level of anesthesia has been reached).
11. That they have consumed analgesics (including prescription and over-the-counter pain medications) during 48 hours prior to surgery, or in the previous 5 days in the case of consumption of inhibitors of the COX-2.
12. Patients unable to abstain from alcohol, psychotropic drugs or sedatives (eg.
benzodiazepines) or other medications that should not be administered due to the risk of interactions for 48 hours before the start of surgery and during the 12 hours following the administration of the study medication.
13. That they have received an experimental drug or used an experimental medical device within the term of the 30 days prior to the selection.
14. Pregnant or lactating women.
15. That they can not comply with the requirements of the study or that in the opinion of the investigator should not take part.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate in a preliminary way the analgesic efficacy measured by the Visual Analog Scale (VAS) 6 hour before administration of a single dose of the fixed-dose combination of ibuprofen (arginate) 400 mg with two dose of intravenous medication versus tramadol 100 mg IV, controlled with placebo.;<br> Secondary Objective: To estimate the measure and variability of the analgesic effect of each of the ibuprofen combinations (arginate) and tramadol IV vs placebo.<br> To estimate the measure and variability of the analgesic effect of tramadol 100 mg IV vs placebo.<br> To evaluate the safety and tolerability of each medication or combination used in order to improve the patients safety.<br> ;Primary end point(s): intensity of pain, measured through a Scale Visual Analogic (VAS);Timepoint(s) of evaluation of this end point: 6 hours after the administration of the investigational medication