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Sucking and Sucrose as Pain Relief for Infants

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ClinicalTrials.gov Identifier: NCT00805623
Recruitment Status : Unknown
Verified December 2008 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 9, 2008
Last Update Posted : December 9, 2008
Sponsor:
Information provided by:
Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Pain Dietary Supplement: sucrose Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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 Start Date : March 2009
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: AW
no pacifier , no sucrose
Active Comparator: AS
sucrose without pacifier
Dietary Supplement: sucrose
1 cc of sucrose 33.5% with or without pacifier
Other Name: no other name
No Intervention: PW
Experimental: PS
Pacifier and sucrose interventional
Dietary Supplement: sucrose
1 cc of sucrose 33.5% with or without pacifier
Other Name: no other name



Primary Outcome Measures :
  1. reduced pain scoring [ Time Frame: 10 minutes ]

Secondary Outcome Measures :
  1. better Parent's scoring to the child's behavior [ Time Frame: 10 minutes ]


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Ages Eligible for Study:   3 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805623


Contacts
Contact: Vered Hofer, MD 972-3-9253681 veredho@clalit.org.il
Contact: Rachel Efrat, MD 972-3-9253279 pedpain@clalit.org.il

Locations
Israel
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Rachel Efrat, MD Schneider Children's Medical Center, Israel

Responsible Party: Schneider Children's Medical Center of Israel
ClinicalTrials.gov Identifier: NCT00805623     History of Changes
Other Study ID Numbers: 004994
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: December 9, 2008
Last Verified: December 2008

Keywords provided by Rabin Medical Center:
sucrose
sucking
pain relief
infant
require venous puncture