Intravenous Cetirizine vs Intravenous Diphenhydramine for the Prevention of Hypersensitivity Infusion Reactions: Results of an Exploratory Phase 2 Study.
Jarrod P Holmes, Julio A Peguero, R Campbell Garland and 4 others
PMID 34555839WHAT IT FOUND
Infusion reactions occurred in 11.8% of patients given IV cetirizine and 17.6% given IV diphenhydramine before cancer infusions.
Cetirizine also had lower sedation scores and 24 minutes less time to discharge readiness, but this was a small phase 2 feasibility study.
Key findings
01In the primary outcome, infusion reactions occurred in 2 of 17 patients given IV cetirizine and 3 of 17 patients given IV diphenhydramine.
02Patient-rated sedation scores were lower with IV cetirizine than IV diphenhydramine at 1 hour, 2 hours, and discharge.
03Time to readiness for discharge was 24 minutes less with IV cetirizine than IV diphenhydramine (4 hours 18 minutes vs 4 hours 42 minutes).
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
Only 34 patients were randomized, and the study was an exploratory phase 2 pilot with no sample size calculation. It was designed to assess feasibility and baseline response, not to prove that one antihistamine prevents more reactions than the other. Sedation and discharge analyses excluded patients with baseline sedation above 0, leaving 15 cetirizine and 13 diphenhydramine patients, and sedating medications or tiredness could confound these outcomes. The protocol was amended during the study to add paclitaxel, so only 9 patients received paclitaxel and the study was too small to control other factors.
Declared interests
TerSera Therapeutics funded the study. Ms North and Drs Young, Brent, and Joseph-Ridge were employed by TerSera. Drs Holmes and Peguero were paid consultants for TerSera. Dr Garland reported no conflicts of interest.
The easy way to misread this
Do not read the 11.8% versus 17.6% reaction rates as proof that IV cetirizine prevents more infusion reactions than IV diphenhydramine. This was a small exploratory phase 2 study with no sample size calculation, and the comparison was descriptive.