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Sucking and Sucrose as Pain Relief for Infants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Rabin Medical Center Identifier:
First received: December 7, 2008
Last updated: December 8, 2008
Last verified: December 2008
Sucking and sucrose have been shown to reduce pain during venous puncture in neonates. Our study is designed to see if sucking and sucrose relieve pain during venous puncture in infants age 3-12 months.

Condition Intervention Phase
Dietary Supplement: sucrose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Partial Blinded Controlled Study to Compare SucroseVs Water, With and Without Pacifier as Pain Reliever During Venous Puncture in Infants 3-12 Months Old

Resource links provided by NLM:

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • reduced pain scoring [ Time Frame: 10 minutes ]

Secondary Outcome Measures:
  • better Parent's scoring to the child's behavior [ Time Frame: 10 minutes ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: AW
no pacifier , no sucrose
Active Comparator: AS
sucrose without pacifier
Dietary Supplement: sucrose
1 cc of sucrose 33.5% with or without pacifier
Other Name: no other name
No Intervention: PW
Experimental: PS
Pacifier and sucrose interventional
Dietary Supplement: sucrose
1 cc of sucrose 33.5% with or without pacifier
Other Name: no other name

Detailed Description:
100 infants age 3-12 months old without neurologic, developmental or cardio-respiratory impairment, needing venous puncture for IV access, or blood aspiration, will be randomly assigned to one of 2 groups - with or without pacifier. During the puncture, each patient with pacifier will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly) . Each patient without pacifier 2 will receive 1 cc of water without pacifier,will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly). FLACC pain score will be used for apin assessment before, during and after the puncture.Comparison of the four groups will be done after the end of the study.

Ages Eligible for Study:   3 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 3-12 months
  • hospitalized in pediatric ward B
  • need venous puncture

Exclusion Criteria:

  • neurological deficit
  • developmental delay
  • Cyanotic heart disease
  • symptomatic respiratory disease
  • known problematic venous access
  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 identifier: NCT00805623

Contact: Vered Hofer, MD 972-3-9253681
Contact: Rachel Efrat, MD 972-3-9253279

Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Principal Investigator: Rachel Efrat, MD Schneider Children's Medical Center, Israel
  More Information

Responsible Party: Schneider Children's Medical Center of Israel Identifier: NCT00805623     History of Changes
Other Study ID Numbers: 004994
Study First Received: December 7, 2008
Last Updated: December 8, 2008

Keywords provided by Rabin Medical Center:
pain relief
require venous puncture processed this record on May 23, 2017