Sucking and Sucrose as Pain Relief for Infants

Overview

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.

Full Title of Study: “Partial Blinded Controlled Study to Compare SucroseVs Water, With and Without Pacifier as Pain Reliever During Venous Puncture in Infants 3-12 Months Old”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2009

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.

Interventions

  • Dietary Supplement: sucrose
    • 1 cc of sucrose 33.5% with or without pacifier

Arms, Groups and Cohorts

  • No Intervention: AW
    • no pacifier , no sucrose
  • Active Comparator: AS
    • sucrose without pacifier
  • No Intervention: PW
  • Experimental: PS
    • Pacifier and sucrose interventional

Clinical Trial Outcome Measures

Primary Measures

  • reduced pain scoring
    • Time Frame: 10 minutes

Secondary Measures

  • better Parent’s scoring to the child’s behavior
    • Time Frame: 10 minutes

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 12 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rabin Medical Center
  • Provider of Information About this Clinical Study
    • Schneider Children’s Medical Center of Israel, Schneider Children’s Medical Center of Israel
  • Overall Official(s)
    • Rachel Efrat, MD, Principal Investigator, Schneider Children’s Medical Center, Israel
  • Overall Contact(s)
    • Vered Hofer, MD, 972-3-9253681, veredho@clalit.org.il

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