Midazolam versus midazolam-promethazine combination for oral sedation in third molar surgery: A randomized...

Oral sedation is widely utilized in dental surgical practice for anxiety management during third molar extractions. Midazolam is one of the most frequently employed drugs; however, the clinical benefits of its association with promethazine have not yet been clearly established.

This is a randomized, double-blind, split-mouth clinical trial. Eighteen anxious patients were included, all with indications for bilateral extraction of impacted or semi-impacted mandibular third molars, presenting similar surgical difficulty on both sides. In one session, patients received 15mg of midazolam alone (Group A), and in another, 15mg of midazolam combined with 25mg of promethazine (Group B). Sedation levels (Ramsay scale), anxiety (Corah scale), and physiological parameters were evaluated.

There was no statistically significant difference in the depth of sedation between the groups (p>0.05). Oxygen saturation and heart rate showed slight, statistically significant variations at specific time points in Group B (p<0.05), although without relevant clinical repercussions. Blood pressure and respiratory rate remained stable across both protocols.

The association of promethazine with midazolam did not increase sedative efficacy compared to midazolam alone. However, it demonstrated clinical safety, proving to be a viable alternative in sedative drug protocols.