RESUMO
BACKGROUND AND STUDY AIM: Diagnostic esophagogastroduodenoscopy (EGD) is uncomfortable for most patients. We determined the efficacy of alprazolam, administered orally or sublingually, as premedication for sedation during EGD. PATIENTS AND METHODS: Adult EGD candidates were randomly allocated to four groups (nâ=â55, each group) and received alprazolam (0.5âmg) sublingually or orally, placebo sublingually or orally at 30 minutes before EGD. Main outcome measures included procedure-related anxiety and pain/discomfort (assessed using 11-point numeric scales), patient overall tolerance (assessed using a 4-point Likert scale), need for intravenous sedation, and willingness to repeat the EGD if necessary. RESULTS: Patients experienced greater reduction in anxiety score after medication with sublingual alprazolam (mean 2.25, standard deviation [SD] 1.73) compared with sublingual placebo (mean 0.10, standard error [SE] 0.15]; Pâ<â0.001) and oral alprazolam (0.63, SE 0.14; Pâ<â0.001). Also, pain/discomfort scores were lower with sublingual alprazolam compared with sublingual placebo (3.29, SE 0.29 vs. 4.16, SD 1.86; Pâ=â0.024), and with oral alprazolam compared with oral placebo (3.48, SD 1.69 vs. 5.13, SD 2.39; P â<â0.001). Patient overall tolerance was better with sublingual alprazolam than with sublingual placebo (Pâ=â0.005) or with oral alprazolam (Pâ=â0.009). Regarding intravenous sedation, there was no difference between sublingual alprazolam and sublingual placebo (10.9â% vs. 10.9â%; Pâ=â0.619) or between oral alprazolam and oral placebo (9.0â% vs. 12.7â%; Pâ=â0.381). Willingness to repeat the procedure was greater with sublingual alprazolam than with sublingual placebo (50.9â% vs. 30.9â%; Pâ=â0.026). CONCLUSIONS: Sublingual alprazolam is an effective premedication for sedation during EGD. It reduces anxiety and pain/discomfort related to EGD and increases patient tolerance and willingness to repeat the EGD if necessary. CLINICAL TRIAL REGISTRATION: NCT01949038 ClinicalTrials.gov.