Effective Analgesia During Routine Immunizations

Study Procedure

Infants meeting inclusion criteria were identified daily by reviewing the list of patients
scheduled for a 2 or 4 month well child visit at the outpatient site. The parent or legal
guardian was approached prior to vaccination by the research assistant for participation in
the study. If the parent/guardian accepted to participate in the vaccine study, the
consenting process was performed and patients were brought to a designated examination room.
Infants of parents or guardians who consented were randomly assigned to one of four study
groups using pre-sealed cards. Ten cards were assigned to each group for a total of 40
cards, which were recycled with each group of 40 infants enrolled into the study. The four
groups of the study included:

1. 2 ml of water 2 minutes prior to immunization and comfort by parent or guardian after
Immunization (Control Group)

2. 2 ml of 24% oral sucrose 2 minutes prior to immunization and comfort by parent or
guardian after immunization (Sucrose Group)

3. 2 ml of water 2 minutes prior to immunization and physical intervention using the 5 S's
by researcher after immunization (Physical Group)

4. 2 ml of 24% oral sucrose 2 minutes prior to immunization and physical intervention
using the 5 S's by researcher after immunization (Physical and Sucrose Group)

Inclusion Criteria:

- infants with a gestational age between 32-42 weeks at delivery and post-natal age of
less than 20 weeks old

Exclusion Criteria:

- acetaminophen or ibuprofen administration within 4 hours prior to immunization,
current neurological disorder, known genetic anomaly, moderate to severe illness with
or without fever at the time of vaccination, anaphylactic reaction to previous dose
of vaccine, or if infant was previously enrolled in the study at 2 months.