Sucking and Sucrose as Pain Relief for Infants

Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00805623
• Other study ID #: 004994
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 7, 2008
• Last updated: December 8, 2008
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: December 2008
• Source: Rabin Medical Center
• Contact: Vered Hofer, MD
• Phone: 972-3-9253681
• Email: veredho[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 12 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Dietary Supplement:
• sucrose
1 cc of sucrose 33.5% with or without pacifier

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduced pain scoring		10 minutes	No
Secondary	better Parent's scoring to the child's behavior		10 minutes	No