Pain Management for Older Infants During Immunisation: A pilot randomised, controlled trial(The MINDI Trial Pilot Study)

Not Applicable

Completed

• Conditions: Acute pain; Pain management; Public Health - Other public health

• Registration Number: ACTRN12614000784617
• Lead Sponsor: niversity of Western Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-23
• Study Completion: 2014-12-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Healthy infants attending the immunisation clinics for the scheduled 12-month immunisations will be recruited.

Exclusion Criteria

The following infants will be excluded from participating in the study:
Breastfeeding infants whose parents choose to breastfeed during immunisation;
Infants who have received an analgesic in the previous 24 hours including paracetamol, so as to not affect the response to painful stimuli during the procedure;
Infants who cannot receive their immunisation due to the presence of immunisation risk factors as cited in the Australian Immunisation Handbook (and as determined by the Immunisation Nurses);
Infants who are not able to be administered a sugar solution (as reported by the parents), and
Non-English speaking parents/guardians that do not have access to English translation at the time of the enrolment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infant pain:<br>Pain will be measured using the validated Modified Behavioural Pain Scale (MBPS).[Baseline, during the first, and during the second injection, and 2 minutes post second (final) injection]

Secondary Outcome Measures

Name	Time	Method
Total duration of crying time:<br>Crying will be defined as the presence of audible negative vocalisations in combination with facial grimacing. <br>[Crying time will be measured from the insertion of the first needle to cessation of crying or up to 3 minutes after the second (last injection), and whichever occurs first.<br>];Incidence of crying (yes/no)[During immunisation ];Parental/guardian perception of infant pain using the Visual Analogue Scale (VAS).[Within 3 minutes after the 2nd (final) injection.]