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Sucking and Sucrose as Pain Relief for Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00805623
First received: December 7, 2008
Last updated: December 8, 2008
Last verified: December 2008
  Purpose

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
Pain
Dietary Supplement: sucrose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • better Parent's scoring to the child's behavior [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00805623

Contacts
Contact: Vered Hofer, MD 972-3-9253681 veredho@clalit.org.il
Contact: Rachel Efrat, MD 972-3-9253279 pedpain@clalit.org.il

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

No publications provided

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

Keywords provided by Rabin Medical Center:
sucrose
sucking
pain relief
infant
require venous puncture

ClinicalTrials.gov processed this record on November 25, 2014