A randomised controlled trial of oral glucose for pain relief in 2 month old infants undergoing immunisatio

Not Applicable

Completed

• Conditions: immunisation pain in infants; Public Health - Health promotion/education; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12610000069055
• Lead Sponsor: niversity of Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Healthy full-term infants
Attending child health clinics in Irbid city in Jordan, for routine 2 month immunisation

Exclusion Criteria

Born Preterm (<34 completed weeks);
Experienced any prior surgery or illness (eg. circumcision);
Unwell for any reason eg fever >37.8C; complaining of any signs or symptoms of infectious disease (eg tonsillitis);
Have had a severe reaction to a prior immunisation;
Have had a severe reaction after eating eggs; Have had convulsions in the past or any other neurological disorders; have had or are having treatment for cancer; have had pain killers in the previous 24 hours; Have any illness which affects the immune system, Are taking any medicine that affects the immune system eg, immunosuppresants or high dose sterioids - these are all the National Immunisation Recommended eligibility criteria for infants undergoing immunisation in Jordan.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain scored using the Modified Behavioural Pain Scale (MBPS)[Procedure is videotaped to assess MBPS at three time periods<br>Time #1: Pre-Procedure (15 seconds) <br>Time #2: Intra-Procedure (10-20 secs) <br>Time #3: Post-Procedure (0-20) seconds after last injection<br>Filming continued for 2 minutes after procedure for assessment of secondary outcome]

Secondary Outcome Measures

Name	Time	Method
Crying duration[Procedure is videotaped to assess MBPS at three time periods<br>Time #1: Pre-Procedure (15 seconds) <br>Time #2: Intra-Procedure (10-20 secs) <br>Time #3: Post-Procedure (0-20) seconds after last injection<br>Filming continued for 2 minutes after procedure for assessment of crying time]