Expired Study
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Norfolk, Virginia 23507


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.

Study summary:

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.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Effective Analgesia During Routine Immunizations

Official Title:

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

Overall Status:


Study Phase:




Minimum Age:

2 Months

Maximum Age:

4 Months

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital of The King's Daughters

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Observational Model: Case Control, Time Perspectiv

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:John W Harrington, MD
Principal Investigator
Children's Hospital of The King's Daughters

Study Dates

Start Date:June 2010
Completion Date:March 2012
Completion Type:Actual
Primary Completion Date:September 2010
Primary Completion Type:Actual
Verification Date:July 2015
Last Changed Date:July 28, 2015
First Received Date:June 3, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:control
Description:water and normal physical comfort provided by mom
Study Arm Type:Other
Arm Name:sucrose
Description:sugar and normal physical comfort provided by mom
Study Arm Type:Other
Arm Name:physical intervention
Description:physical intervention using the 5 S's and water
Study Arm Type:Other
Arm Name:physical intervention and sucrose
Description:Physical intervention using the 5 S's and sugar water

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital of The King's Daughters

Samples and Retentions

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.
Sample Method:Probability Sample

Study References

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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
Citation:Karp, Harvey. The Happiest Baby on the Block. New York, NY: Bantam Books; 2003
Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
Citation:Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001069. doi: 10.1002/14651858.CD001069.pub3. Review. Update in: Cochrane Database Syst Rev. 2013;1:CD001069.
Reference Type:Reference
Citation:Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50. doi: 10.1016/S0140-6736(09)61208-3.
Reference Type:Reference
Citation:Taddio A, Manley J, Potash L, Ipp M, Sgro M, Shah V. Routine immunization practices: use of topical anesthetics and oral analgesics. Pediatrics. 2007 Sep;120(3):e637-43.
Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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