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Sucking and Sucrose as Pain Relief for Infants

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00805623
Enrollment
100
Registered
2008-12-09
Start date
2009-03-31
Completion date
2009-10-31
Last updated
2008-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

sucrose, sucking, pain relief, infant, require venous puncture

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.

Interventions

DIETARY_SUPPLEMENTsucrose

1 cc of sucrose 33.5% with or without pacifier

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Months to 12 Months
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

Design outcomes

Primary

MeasureTime frame
reduced pain scoring10 minutes

Secondary

MeasureTime frame
better Parent's scoring to the child's behavior10 minutes

Countries

Israel

Contacts

Primary ContactVered Hofer, MD
veredho@clalit.org.il972-3-9253681
Backup ContactRachel Efrat, MD
pedpain@clalit.org.il972-3-9253279

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026