Effective Analgesia During Routine Immunizations

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368861
• Other study ID #: EVMS
• Status: Completed
• Phase: N/A
• First received: June 3, 2011
• Last updated: July 28, 2015
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: July 2015
• Source: Children's Hospital of The King's Daughters
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 4 Months

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	Children's Hospital of The King's Daughters	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of The King's Daughters

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure 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.	Does the 5 S's improve the percieved pain of infants receiving vaccinations. The Modified Riley Pain Scale which measure 3 aspects of pain was utilized. The scale is validated for the assessment of acute pain in preterm and term infants.	every 15 sec	No

External Links

•   Demonstration of the 5 S's