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Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Temperature effect on nausea during fluorescein angiography.
Ophthalmology 2001 July
PURPOSE: Nausea is the most common adverse effect of fluorescein angiography (FA). Warming of fluorescein dye before injection has been reported anecdotally to decrease nausea frequency. We examined the effect of warmed fluorescein 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 temperature (control group) or dye prewarmed to body temperature (study group). All patients were masked to the dye temperature. After FA, patients were questioned regarding any adverse effects experienced.
MAIN OUTCOME MEASURES: Presence or absence of reported nausea associated with FA.
RESULTS: Adverse reactions were reported for 39 of the angiograms (7.1%), including 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 was found between the two groups (P = 0.28). The sample sizes used allow an 80% power for detecting a clinically significant difference of 4% adverse effects in one group and 10% in the other group when testing at a significance level of 5%.
CONCLUSIONS: Warming of fluorescein dye does not significantly alter the incidence of nausea reported with 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 temperature (control group) or dye prewarmed to body temperature (study group). All patients were masked to the dye temperature. After FA, patients were questioned regarding any adverse effects experienced.
MAIN OUTCOME MEASURES: Presence or absence of reported nausea associated with FA.
RESULTS: Adverse reactions were reported for 39 of the angiograms (7.1%), including 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 was found between the two groups (P = 0.28). The sample sizes used allow an 80% power for detecting a clinically significant difference of 4% adverse effects in one group and 10% in the other group when testing at a significance level of 5%.
CONCLUSIONS: Warming of fluorescein dye does not significantly alter the incidence of nausea reported with FA.
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