Ahmad Shavakhi 1 , Soghry Soleiman 1 , Ali Gholamrezaei 2 , Mahsa Khodadoostan 1 , Sara Shavakhi 3 , Abdolmajid Tahery 4 , Mohammad Minakari 1 Show Affiliations »
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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. © Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities: Population
Interventions
Outcomes
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. © Georg Thieme Verlag KG Stuttgart · New York.
Entities: Chemical
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Year: 2014
PMID： 24977401 DOI： 10.1055/s-0034-1377305
Source DB: PubMed Journal: Endoscopy ISSN： 0013-726X Impact factor: 10.093