NCT01368861

Effective Analgesia During Routine Immunizations

Effective Analgesia Using the 5 S's During Routine Immunizations at 2 and 4 Months

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: Children's Hospital of The King's Daughters · Academic / Other
• Sex: All
• Age: 2 Months – 4 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to observe and measure the analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits.

Detailed description

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)

Conditions

• Pain

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-09-01
• Completion: 2012-03-01
• First posted: 2011-06-08
• Last updated: 2015-07-29

Locations

1 site across 1 country: United States