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Sucking and Sucrose as Pain Relief for Infants

NCT ID: NCT00805623

Last Updated: 2008-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-10-31

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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sucrose sucking pain relief infant require venous puncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AW

no pacifier , no sucrose

Group Type NO_INTERVENTION

No interventions assigned to this group

AS

sucrose without pacifier

Group Type ACTIVE_COMPARATOR

sucrose

Intervention Type DIETARY_SUPPLEMENT

1 cc of sucrose 33.5% with or without pacifier

PW

Group Type NO_INTERVENTION

No interventions assigned to this group

PS

Pacifier and sucrose interventional

Group Type EXPERIMENTAL

sucrose

Intervention Type DIETARY_SUPPLEMENT

1 cc of sucrose 33.5% with or without pacifier

Interventions

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sucrose

1 cc of sucrose 33.5% with or without pacifier

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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no other name

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Schneider Children's Medical Center of Israel

Principal Investigators

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Rachel Efrat, MD

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center, Israel

Locations

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Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Vered Hofer, MD

Role: CONTACT

Phone: 972-3-9253681

Email: [email protected]

Rachel Efrat, MD

Role: CONTACT

Phone: 972-3-9253279

Email: [email protected]

Other Identifiers

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004994

Identifier Type: -

Identifier Source: org_study_id