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


CONCLUSIONS
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.
Micalizzi
Marlynne
M
Early Development and Clinical Pharmacology, Wyeth Research, Collegeville, PA 19426, USA. micalim@wyeth.com
Fraga
Polly
P
Meng
Xu
X
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects*; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D003402:Creatine Kinase / Q000097:blood; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D010146:Pain / Q000139:chemically induced; D010147:Pain Measurement; D000077402:Pantoprazole; D010689:Phlebitis / Q000139:chemically induced; D054328:Proton Pump Inhibitors
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D000077402:Pantoprazole; D003402:Creatine Kinase