EFFICACY AND SAFETY OF LIDOCAINE WITH CLONIDINE FOR MAXILLARY INFILTRATION ANESTHESIA IN PATIENTS WITH DIABETES MELLITUS TYPE 2: DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL

Abstract

Objectives

This clinical trial aimed to evaluate and compare parameters of intraoral soft tissue anesthesia and cardiovascular function, and prevalence of local side effects in patients with and without diabetes mellitus type 2 (DMT2), after maxillary infiltration anesthesia obtained with 2% lidocaine with either clonidine (15mcg/ml) or epinephrine (1:100.000).

Methods

Sixty-three DMT2 and 52 nondiabetic (H) patients scheduled for tooth extraction were randomly assigned to receive one of the local anesthetic solutions for maxillary infiltration anesthesia: 2 mL of lidocaine with clonidine (LC) or 2 mL of lidocaine with epinephrine (LE). Parameters of soft tissue anesthesia (onset, duration and width of anesthetic field) were evaluated by pinprick test. Systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were monitored with patient monitor, before and until 30 minutes after anesthesia application. Presence of postoperative hyperalgesia and paresthesia during 7 postoperative days was tested with ethylene-chloride spray and monofilaments set for quantitative sensory testing, respectively. Requests for rescue analgesic were recorded for 24 hours after tooth extraction.

Results

Onset of maxillary infiltration anesthesia was significantly shorter in DMT2 vs. H groups (P < .05), regardless of local anesthetic solution used. Duration of anesthesia was 59% longer in DMT2-LE vs. H-LE (P < .05), and 28% longer in DMT2-LC vs. H-LC groups (P < .05). Maxillary infiltration anesthesia lasted 37,9% longer in DMT2-LE vs. DMT2-LC (182.09 ± 57.86 min vs. 139.48 ± 21.86 min) (P < .05). Width of anesthetic field was significantly increased in diabetic vs. nondiabetic participants (P < .05), as well as in DMT2-LE vs. DMT2-LC (35.19 ± 1.67mm vs. 27.07 ± 1.06 mm) (P < .05). SBP was significantly decreased within DM-LC and H-LC groups from 15th to 30th minute, in comparison with baseline values. Significant increase in HR was observed from 5th to 30th minute in diabetic and nondiabetic patients who received LE, compared to baseline values. Postoperative paresthesia was significantly more present in DMT2-LE vs. DMT2-LC (P < .05), while it was not observed in nondiabetic patients.

Conclusions

Shorter onset and prolonged duration of maxillary infiltration anesthesia are present in DMT2 setting. Clonidine appears to be a safe alternative to epinephrine for intraoral anesthesia in DMT2, with respect to anesthetic efficacy, cardiovascular safety and prevalence of local side effects.