Alex R Kemper1, Elizabeth D Barnett2, Emmanuel B Walter3, Christoph Hornik3, Natalie Pierre-Joseph2, Karen R Broder4, Michael Silverstein2, Theresa Harrington4. 1. Division of Ambulatory Pediatrics, Nationwide Children's Hospital, Columbus, Ohio; alex.kemper@nationwidechildrens.org. 2. Department of Pediatrics, School of Medicine, Boston University, Boston, Massachusetts. 3. Department of Pediatrics, Duke University, Durham, North Carolina; and. 4. Division of Healthcare Quality Promotion, Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.
Abstract
BACKGROUND AND OBJECTIVES: Postvaccination syncope can cause injury. Drinking water prephlebotomy increases peripheral vascular tone, decreasing risk of blood-donation presyncope and syncope. This study evaluated whether drinking water prevaccination reduces postvaccination presyncope, a potential syncope precursor. METHODS: We conducted a randomized trial of subjects aged 11 to 21 years receiving ≥1 intramuscular vaccine in primary care clinics. Intervention subjects were encouraged to drink 500 mL of water, with vaccination recommended 10 to 60 minutes later. Control subjects received usual care. Presyncope symptoms were assessed with a 12-item survey during the 20-minutes postvaccination. Symptoms were classified with a primary cutoff sensitive for presyncope, and a secondary, more restrictive cutoff requiring greater symptoms. Results were adjusted for clustering by recruitment center. RESULTS: There were 906 subjects randomly assigned to the control group and 901 subjects randomly assigned to the intervention group. None had syncope. Presyncope occurred in 36.2% of subjects by using the primary definition, and in 8.0% of subjects by using the restrictive definition. There were no significant differences in presyncope by intervention group for the primary (1-sided test, P = .24) or restrictive outcome (1-sided test, P = .17). Among intervention subjects vaccinated within 10 to 60 minutes after drinking all 500 mL of water (n = 519), no reduction in presyncope was observed for the primary or restrictive outcome (1-sided tests, P = .13, P = .17). In multivariable regression analysis, presyncope was associated with younger age, history of passing out or nearly passing out after a shot or blood draw, prevaccination anxiety, receiving >1 injected vaccine, and greater postvaccination pain. CONCLUSIONS: Drinking water before vaccination did not prevent postvaccination presyncope. Predictors of postvaccination presyncope suggest opportunities for presyncope and syncope prevention interventions.
RCT Entities:
BACKGROUND AND OBJECTIVES:Postvaccination syncope can cause injury. Drinking water prephlebotomy increases peripheral vascular tone, decreasing risk of blood-donation presyncope and syncope. This study evaluated whether drinking water prevaccination reduces postvaccination presyncope, a potential syncope precursor. METHODS: We conducted a randomized trial of subjects aged 11 to 21 years receiving ≥1 intramuscular vaccine in primary care clinics. Intervention subjects were encouraged to drink 500 mL of water, with vaccination recommended 10 to 60 minutes later. Control subjects received usual care. Presyncope symptoms were assessed with a 12-item survey during the 20-minutes postvaccination. Symptoms were classified with a primary cutoff sensitive for presyncope, and a secondary, more restrictive cutoff requiring greater symptoms. Results were adjusted for clustering by recruitment center. RESULTS: There were 906 subjects randomly assigned to the control group and 901 subjects randomly assigned to the intervention group. None had syncope. Presyncope occurred in 36.2% of subjects by using the primary definition, and in 8.0% of subjects by using the restrictive definition. There were no significant differences in presyncope by intervention group for the primary (1-sided test, P = .24) or restrictive outcome (1-sided test, P = .17). Among intervention subjects vaccinated within 10 to 60 minutes after drinking all 500 mL of water (n = 519), no reduction in presyncope was observed for the primary or restrictive outcome (1-sided tests, P = .13, P = .17). In multivariable regression analysis, presyncope was associated with younger age, history of passing out or nearly passing out after a shot or blood draw, prevaccination anxiety, receiving >1 injected vaccine, and greater postvaccination pain. CONCLUSIONS:Drinking water before vaccination did not prevent postvaccination presyncope. Predictors of postvaccination presyncope suggest opportunities for presyncope and syncope prevention interventions.
Authors: Chih-Cherng Lu; André Diedrich; Che-Se Tung; Sachin Y Paranjape; Paul A Harris; Daniel W Byrne; Jens Jordan; David Robertson Journal: Circulation Date: 2003-11-17 Impact factor: 29.690