Mepivacaine-Tramadol on the Success of Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis
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|ClinicalTrials.gov Identifier: NCT02110966|
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : October 31, 2014
The purpose of this study is to evaluate the success of inferior alveolar nerve block, after the local application of Mepivacaine plus Tramadol in patients with symptomatic irreversible pulpitis. Also, to evaluate the duration of the anesthetic effect when using Mepivacaine plus Tramadol in the same anesthetic technique and patients group.
Local application of mepivacaine plus tramadol increases the successful of inferior alveolar nerve block in patients with irreversible pulpitis.
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Irreversible Pulpitis||Drug: Mepivacaine Drug: Mepivacaine plus Tramadol||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of the Combination Mepivacaine-Tramadol on the Success of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial.|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Mepivacaine plus Tramadol
1.3 ml of Mepivacaine 2% epinephrine 1:100000 mixed with 0.5 ml of Tramadol (50mg/ml) will be used for the anesthetic blockade in the experimental group
Drug: Mepivacaine plus Tramadol
0.5 ml of Tramadol mixed with 1.3 ml of Mepivacaine.
Other Name: Tradol
Active Comparator: Mepivacaine
The control group will receive the inferior alveolar nerve block using 1.8 ml of Mepivacaine 2% epinephrine 1: 100000.
Drug: Tramadol 1.8 ml of Mepivacaine 2% epinephrine 1:100000.
Other Name: Dentocaín
- success of the inferior alveolar nerve block [ Time Frame: 0-30 minutes ]The anesthetic blockade will be assessed by a three step examination: lip numbess, positive/negative response to cold testing and clinical discomfort during endodontic access. Inferior alveolar nerve block success will be defined as the absence of pain during any of these evaluations and if patients report pain an analogue visual scale will be used. Also, the patient will reported the level of pain in the application of the inferior alveolar nerve block using mepivacaine and mepivacaine plus tramadol and local and systemic side effects will be monitored.
- Anesthetic effect duration [ Time Frame: 0-14 hours ]The time of the anesthetic effect will be evaluated in patients in whom anesthetic success is achieved, and also the consume of emergency and rescue post-operative analgesics. Side effects will also be monitored during this period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110966
|Endodontics Master Degree program, Dentistry Faculty, San Luis Potosi University|
|San Luis Potosi, Mexico, 78290|
|Principal Investigator:||Laura Rodríguez, DDS||Universidad Autónoma San Luis Potosí|
|Study Director:||Daniel Chavarria, MSc, PhD||Universidad Autonoma San Luis Potosi|
|Study Chair:||Amaury Pozos, MSc, PhD||Universidad Autonoma San Luis Potosi|