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 (n?=?55, each group) and received alprazolam (0.5?mg) 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]; P?0.001) and oral alprazolam (0.63, SE 0.14; P?0.001). Also, pain/discomfort scores were lower with sublingual alprazolam compared with sublingual placebo (3.29, SE 0.29 vs. 4.16, SD 1.86; P?=?0.024), and with oral alprazolam compared with oral placebo (3.48, SD 1.69 vs. 5.13, SD 2.39; P ?0.001). Patient overall tolerance was better with sublingual alprazolam than with sublingual placebo (P?=?0.005) or with oral alprazolam (P?=?0.009). Regarding intravenous sedation, there was no difference between sublingual alprazolam and sublingual placebo (10.9?% vs. 10.9?%; P?=?0.619) or between oral alprazolam and oral placebo (9.0?% vs. 12.7?%; P?=?0.381). Willingness to repeat the procedure was greater with sublingual alprazolam than with sublingual placebo (50.9?% vs. 30.9?%; P?=?0.026).
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