Purpose: Nausea is the most common adverse effect of fluorescein angiograph
y (FA), Warming of fluorescein dye before injection has been reported anecd
otally to decrease nausea frequency, We examined the effect of warmed fluor
escein dye on the frequency of adverse effects of FA,
Design: Prospective, randomized, controlled trial,
Participants: Five hundred forty-seven angiograms performed on 394 patients
; 273 were in the control group and 274 were in the study group.
Methods: Patients were alternately assigned to FA using dye at room tempera
ture (control group) or dye prewarmed to body temperature (study group). Al
l patients were masked to the dye temperature, After FA, patients were ques
tioned regarding any adverse effects experienced.
Main Outcome Measures: Presence or absence of reported nausea associated wi
th FA.
Results: Adverse reactions were reported for 39 of the angiograms (7.1%), i
ncluding 32 procedures for which nausea was reported (5.9%). No significant
difference in the frequency of adverse reactions was found between the two
groups (P = 0.41), No significant difference in the frequency of nausea wa
s found between the two groups (P = 0.28), The sample sizes used allow an 8
0% power for detecting a clinically significant difference of 4% adverse ef
fects in one group and 10% in the other group when testing at a significanc
e level of 5%.
Conclusions: Warming of fluorescein dye does not significantly alter the in
cidence of nausea reported with FA, Ophthalmology 2001;108:1193-1195 (C) 20
01 by the American Academy of Ophthalmology.