Effective Analgesia During Routine Immunizations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Children's Hospital of The King's Daughters.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
John Harrington, Children's Hospital of The King's Daughters
ClinicalTrials.gov Identifier:
NCT01368861
First received: June 3, 2011
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effective Analgesia Using the 5 S's During Routine Immunizations at 2 and 4 Months

Further study details as provided by Children's Hospital of The King's Daughters:

Primary Outcome Measures:
  • 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. [ Time Frame: every 15 sec ] [ Designated as safety issue: No ]
    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.


Enrollment: 230
Study Start Date: June 2010
Estimated Study Completion Date: March 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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)
  Eligibility

Ages Eligible for Study:   2 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368861

Locations
United States, Virginia
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Children's Hospital of The King's Daughters
Investigators
Principal Investigator: John W Harrington, MD Children's Hospital of The King's Daughters
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Harrington, Associate Professor, Children's Hospital of The King's Daughters
ClinicalTrials.gov Identifier: NCT01368861     History of Changes
Other Study ID Numbers: EVMS
Study First Received: June 3, 2011
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of The King's Daughters:
infant
immunizations
pain
pain management
vaccines
analgesia

ClinicalTrials.gov processed this record on July 24, 2014