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

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Dietary supplement: sucrose

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
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vered Hofer, MD; Phone Number: 972-3-9253681; Email: veredho@clalit.org.il
• Study Contact Backup: Name: Rachel Efrat, MD; Phone Number: 972-3-9253279; Email: pedpain@clalit.org.il

Study Locations

• Israel
  • Petah Tikva, Israel, 49202
    • Schneider Children's Medical Center of Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reduced pain scoring	10 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
better Parent's scoring to the child's behavior	10 minutes

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Rachel Efrat, MD, Schneider Children's Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): August 1, 2009
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: December 7, 2008
• First Submitted That Met QC Criteria: December 8, 2008
• First Posted (Estimate): December 9, 2008

Study Record Updates

• Last Update Posted (Estimate): December 9, 2008
• Last Update Submitted That Met QC Criteria: December 8, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: pain relief; infant; sucrose; sucking; require venous puncture
• Other Study ID Numbers: 004994