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Sucking and Sucrose as Pain Relief for Infants

Clalit Health Services logo

Clalit Health Services

Status and phase

Unknown
Phase 4

Conditions

Pain

Treatments

Dietary Supplement: sucrose

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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 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.

Enrollment

100 estimated patients

Sex

All

Ages

3 to 12 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 4 patient groups

AW
No Intervention group
Description:
no pacifier , no sucrose
AS
Active Comparator group
Description:
sucrose without pacifier
Treatment:
Dietary Supplement: sucrose
PW
No Intervention group
PS
Experimental group
Description:
Pacifier and sucrose interventional
Treatment:
Dietary Supplement: sucrose

Trial contacts and locations

1

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Central trial contact

Vered Hofer, MD; Rachel Efrat, MD

Data sourced from clinicaltrials.gov

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