Effects of Metoclopramide Orally Disintegrating Tablet in Optimizing Late Outpatient Endoscopy: A Randomized Double-Blind Placebo-Controlled Clinical Trial
Aims: Metoclopramide has been used as a gastro-kinetic agent but the safety and effects of different preparations of metoclopramide on preparation for outpatient endoscopy are largely unknown. The study aimed to evaluate the (1) Safety of using ODT (orally disintegrating tablet) or TT (traditional tablet) metoclopramide pre-endoscopy in non-fasting patients compared with placebo (2) Impact of ODT or TT metoclopramide on sedation and recovery times compared with placebo. Methods: A double blind randomized placebo-controlled trial with 3 arms; Metoclopramide ODT (n = 43), Metoclopramide TT (n = 43) and Placebo (n = 43). Results: Metoclopramide ODT had fewer adverse events compared with TT or placebo. Recovery time was significantly shorter with use of either metoclopramide versus placebo (P < 0.001) & total sedation time was also significantly shorter in the metoclopramide groups versus placebo (P < 0.001). Conclusion: Metoclopramide ODT is safe and beneficial in endoscopic procedures requiring limited access to food and liquid.
References
[1]
Minoli, G., Meucci, G., Bortoli, A., Garripoli, A., Gullotta, R., Leo, P., Pera, A., Prada, A., Rocca, F. and Zambelli, A. (2000) The ASGE Guidelines for the Appropriate Use of Colonoscopy in an Open Access System. Gastrointest Endosc, 52, 39-44.
[2]
Cohen, L.B., Delegge, M.H., Aisenberg, J., Brill, J.V., Inadomi, J.M., Kochman, M.L., et al. (2007) AGA Institute Review of Endoscopic Sedation. Gastroenterology, 133, 675-701.
[3]
Frossard, J.L., Spahr, L., Queneau, P.E., Giostra, E., Burckhardt, B., Ory, G., et al. (2002) Erythromycin Intravenous Bolus Infusion in Acute Upper Gastrointestinal Bleeding: A Randomized, Controlled, Double-Blind Trial. Gastroenterology, 123, 17-23.
[4]
Albibi, R. and McCallum, R.W. (1983) Metoclopramide: Pharmacology and Clinical Application. Annals of Internal Medicine, 98, 86-95.
[5]
Fass, R., Pieniaszek, H.J. and Thompson, J.R. (2009) Pharmacokinetic Comparison of Orally-Disintegrating Metoclopramide with Conventional Metoclopramide Tablet Formulation in Healthy Volunteers. Alimentary Pharmacology & Therapeutics, 30, 301-306.
[6]
Barkun, A.N., Bardou, M., Martel, M., Gralnek, I.M. and Sung, J.J. (2010) Prokinetics in Acute Upper GI Bleeding: A Meta-Analysis. Gastrointestinal Endoscopy, 72, 1138-1145.
[7]
Monroe, W.E., Leib, M.S., Matz, M.E., Davenport, D.J., Nelson, L.P. and Kenny, J.E. (1992) Evaluation of Metoclopramide Hydrochloride as an Aid for Passage of a Flexible Endoscope into the Duodenum of Dogs. American Journal of Veterinary Research, 53, 149-152.
[8]
Korn, M. (1984) Use of Metoclopramide in the Preparation of Patients over 75 for Gastroscopy. The Annals of Gastroenterology & Hepatology (Paris), 20, 225-227.
