Effective Analgesia During Routine Immunizations

NCT01368861 | Completed

• 1 other identifier: EVMS
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

infant; immunizations; pain; pain management; vaccines; analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

control

water and normal physical comfort provided by mom

sucrose

sugar and normal physical comfort provided by mom

physical intervention

physical intervention using the 5 S's and water

physical intervention and sucrose

Physical intervention using the 5 S's and sugar water

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All patients were enrolled from the General Academic Pediatric outpatient practice located at The Children's Hospital of The King's Daughters in Norfolk, VA. This practice serves a predominantly urban, Medicaid enrolled, African-American population and has approximately 30,000 annual visits per year.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of The King's Daughters: lead

Study Sites (1)

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Location

Related Publications (30)

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  PMID: 22508924 DERIVED

Related Links

• Demonstration of the 5 S's

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• John W Harrington, MD

  Children's Hospital of The King's Daughters

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 8, 2011
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2012
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

US (1)