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Clinical Trials/NCT00805623
NCT00805623
Unknown
Phase 4

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

Rabin Medical Center1 site in 1 country100 target enrollmentMarch 2009
ConditionsPain

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Pain
Sponsor
Rabin Medical Center
Enrollment
100
Locations
1
Primary Endpoint
reduced pain scoring
Last Updated
17 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
October 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

reduced pain scoring

Time Frame: 10 minutes

Secondary Outcomes

  • better Parent's scoring to the child's behavior(10 minutes)

Study Sites (1)

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