Oral Water Hydration to Prevent Post-Vaccination Presyncope
Condition: Presyncope; Syncope
MeSH terms: Syncope
Study type: Interventional

Summary: 
      This is a randomized controlled open-label trial. During the study, adolescents and young
      adults scheduled to receive at least one intra-muscular (IM) vaccine will receive either oral
      water hydration in addition to standard care or standard of care alone to evaluate the effect
      of water hydration on the primary outcome of presyncope. This study will also evaluate the
      acceptability of pre-vaccination hydration among adolescents and young adults.
    

Detailed description: 
      Post-vaccination syncope is a rare but potentially serious adverse event in adolescents and
      young adults. Because few data are available regarding post-vaccination syncope, evidence
      regarding presyncope and syncope after blood donation provides useful insight. Based on
      studies of blood donors, acute water loading fifteen minutes prior to vaccination with 500 mL
      of water might reduce the risk of syncope. However, the degree to which hydration attenuates
      the risk of post-vaccination syncope or presyncope is unknown. Furthermore, little is known
      about the acceptability of pre-vaccination hydration to adolescents and young adults.

      The objective of this study is to conduct a study to evaluate the acceptability and impact of
      oral hydration to prevent presyncope following vaccination in adolescents and young adults 11
      through 21 years of age. The primary objectives are to determine if pre-vaccination hydration
      decreases the rate of presyncope in adolescents and young adults receiving at least one
      intra-muscular (IM) vaccine and to determine if pre-vaccination hydration is acceptable to
      adolescents and young adults.

      This is a randomized controlled open-label study in adolescents and young adults receiving at
      least one IM vaccine. Vaccine administration will be part of routine care and will not be a
      study procedure. Adolescents and young adults 11- through 21 years of age will be eligible
      for participation. Minimal subject exclusion criteria will be used to best reflect how
      pre-vaccination hydration could be used outside of the controlled trial setting. For all
      primary and secondary objectives, data will be collected before and after vaccination, with
      data collection to be completed on the day of enrollment.
    

Intervention name(s): Oral Water Hydration
Intervention type(s): Other
Intervention description(s): Subjects in the hydration group will be allowed up to 15 minutes to drink up to 500 milliliters (mL) of water prior to the vaccines. Subjects will be encouraged to drink the entire 500 mL; however, they are free to drink as much as they want and can finish before the end of the 15-minute period. Subjects will be instructed not to share the water and to not otherwise empty the bottle. As with the control group, subjects will be instructed not to eat or drink anything else for the duration of the study, unless clinically indicated (e.g., as part of management of presyncope or syncope).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: presyncope; syncope; adolescent; young adult; immunization; vaccination; water consumption