Effect of the administration of tramadol on the success of the inferior anesthetic blocking technique in mandibular molars with acute inflammatio

• Conditions: Anesthetic failure of the inferior alveolar nerve block in mandibular molars with irreversible pulpitis; MedDRA version: 17.0Level: PTClassification code 10054799Term: Perioperative analgesiaSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 17.0Level: PTClassification code 10037464Term: Pulpitis dentalSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.0Level: LLTClassification code 10038286Term: Regional nerve blockSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 17.0Level: LLTClassification code 10002325Term: Anesthesia localSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2013-004741-16-ES
• Lead Sponsor: Ana de Pedro Muñoz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-21
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

ASA I patients between 18 and 64 years old with acute irreversible pulpitis in a mandibular molar. The diagnosis of acute irreversible pulpitis would be given by the following symptoms:
- spontaneous pain,
- exaggerated and prolonged sensitivity to cold,
- sensitivity to touch, pulp exposure and / or
- pain with postural changes.
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Hypersensitivity to any of the drugs used in the study,
- Pregnancy or lactation
- Use of analgesics in the last 24 hours
- Asthma patients
- Patients with renal or hepatic insufficiency
- Patients taking anticonvulsants
- Patients taking MAOI's
- Patients taking barbiturates, benzodiazepines, phenothiazines or other tranquilizers drugs, sedatives or hypnotics
- Drug dependent patients
- Patients with hypothyroidism
- Patients taking digoxin.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To increase the anesthetic efficacy of the inferior alveolar nerve block with 4% articaine with 1:100000 epinephrine by the preoperative administration of 50 mg of submucous tramadol in patients with irreversible pulpitis in mandibular molars;Secondary Objective: Enhance the effect of the local anesthetic by the administration of tramadol<br><br>Assessement of the postoperative analgesic effect of tramadol<br><br>To provide a greater intra and preoperative analgesia with the local administration of tramadol;Primary end point(s): The primary end point in this trial is to increase the success of the inferior alveolar nerve block in patients with irreversible pulpitis of a mandibular molar in at least a 30%;Timepoint(s) of evaluation of this end point: It's assumed that data for the primary end point could be analyzed after six months from the begining of the trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - To eliminate the need to take postoperative medication<br><br>- To increase the suration of the local anesthetic solution.;Timepoint(s) of evaluation of this end point: The same as for the primary end point