Anesthetic failure of the inferior alveolar nerve block in mandibular molars with irreversible pulpitis MedDRA version: 17.0 Level: PT Classification code 10054799 Term: Perioperative analgesia System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 17.0 Level: PT Classification code 10037464 Term: Pulpitis dental System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0 Level: LLT Classification code 10038286 Term: Regional nerve block System Orga
Conditions
Interventions
Trade Name: TRAMADOL NORMON 100 mg/2 ml Solución inyectable EFG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 8.3 (6.3-13) IC 95%
Other descriptive name: TRAMADOL HYDROCHLORIDE
Conc
Sponsors
Ana de Pedro Muñoz
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Assessement of the postoperative analgesic effect of tramadol 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To eliminate the need to take postoperative medication - 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 | — |
Countries
Spain
Contacts
Public ContactAna de Pedro Muñoz
Ana de Pedro Muñoz
Outcome results
None listed