Comparative tolerability of 2- and 15-minute intravenous infusions of pantoprazole.

Author(s): Micalizzi M, Fraga P, Meng X

Affiliation(s): Early Development and Clinical Pharmacology, Wyeth Research, Collegeville, PA 19426, USA. micalim@wyeth.com

Publication date & source: 2007-09-01, Am J Health Syst Pharm., 64(17):1822-6.

Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

PURPOSE: The safety and tolerability of 80 mg i.v. pantoprazole administered as a 2-minute versus a 15-minute infusion were studied. METHODS: In a single-blind, randomized, multiple-dose, parallel-group study, 48 healthy participants (ages 18-45 years) were randomly assigned for treatment with 80 mg i.v. pantoprazole infused for 2 or 15 minutes once daily for seven days. A blinded evaluator assessed the injection site for phlebitis and infiltration on a 5-point scale at specified intervals. Participants completed the visual analogue scale (VAS) for pain and burning at baseline and at 5 minutes postinjection. RESULTS: More than 99% of the preinfusion and postinfusion infiltration scores and >95% of the phlebitis scores were rated as zero in 48 healthy participants. A total of 7 infiltration scores (1%) and 72 postinfusion phlebitis scores (5%) of greater than 0 were recorded, all of which were mild in nature. Forty-one phlebitis scores of 1 and 1 score of 2 were from 12 participants in the 2-minute group, and 20 scores of 1 and 10 scores of 2 were from 8 participants in the 15-minute group. VAS assessments showed that the perception of pain and burning was not greater in the 2-minute group. There were no significant differences in adverse events between the two groups. CONCLUSION: The safety and tolerability profiles of i.v. pantoprazole administered as a 2-minute infusion were similar to those of the 15-minute infusion. This protocol may result in the savings of staff time with no additional discomfort to the patient.