Sucrose analgesia during needle related procedures in infants and young childre

Not Applicable

Completed

• Conditions: eedle related pain and distress in young children; Needle related pain and distress in young children; Public Health - Other public health

• Registration Number: ACTRN12610000355077
• Lead Sponsor: Denise Harrison

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Site 1: Infants/toddlers aged 12-18 months and pre-school children aged 3-5 years, undergoing scheduled childhood immunisation in the Royal Children’s Hospital Immunisation Centre.

Site 2: Toddlers aged 12-36 months undergoing venepuncture in the Children's Hospital of Eastern Ontario surgical unit.

Exclusion Criteria

Insufficient understanding of English If already eating/drinking sweet solutions or foods
In addition for venepuncture study: If received muscle relaxants or opioid analgesics within preceeding 24 hours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cry duration as assessed by coders blinded to purpose of study, viewing video analysis of procedures, and timing cry duration using stop watch.[Throughout immunisation and venepuncture];Pain score; FLACC (Face, Legs, Arms, Crying, Consolability)[Immunisation study: Upon first injection and 15 & 30 seconds following completion of each injection. <br>Venepuncture: 7 phases prior to commencement, throughout procedure and following completion of procedure:<br>1.Baseline; prior to administration of the study solutions<br>2.Immediately following first dose of the study solution<br>3.Upon commencement of the needle insertion<br>4.30 seconds during the procedure<br>5.60 seconds during the procedure<br>6.Upon completion of the procedure<br>7.60 seconds following completion of the procedure];Parent Visual Analogue Scale (VAS ) on a 0-10 scale.[Upon completion of needle procedures]

Secondary Outcome Measures

Name	Time	Method
Children's Compliance with intervention : (0-3 scale: Fully compliant, Somewhat compliant, Not compliant[Upon completion of needle procedures];Pre-school children only: Self report of pain using Wong-Baker Pain scale[Upon completion of immunisation procedure]