Effectiveness and safety of tetanus vaccine administration by intramuscular vs. subcutaneous route in anticoagulated patients: Randomized clinical trial in primary care.

ABSTRACT:

Design

Prospective, double-blind clinical trial comparing tetanus-diphtheria vaccine administration routes, intramuscular (IM) vs. subcutaneous (SC) injection, in patients with oral anticoagulants. ISRCTN69942081.

Study population

Patients treated with oral anticoagulants, 15 health centers, Vigo (Spain). Sample size, 117 in each group.

Outcome variables

Safety analysis: systemic reactions and, at the vaccine administration site, erythematic, swelling, hematoma, granuloma, pain.Effectiveness analysis: differences in tetanus toxoid antibody titers.Independent variables: route, sex, age, baseline serology, number of doses administered.

Analysis

Following the CONSORT guidelines, we performed an intention-to-treat analysis. We conducted a descriptive study of the v

SUBMITTER: Lago-Deibe FI 

PROVIDER: S-EPMC9813590 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature