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Shortened EMLA plus skin cooling for paediatric vaccination pain: a randomised non-inferiority trial

Shortened EMLA plus skin cooling for paediatric vaccination pain: a randomised non-inferiority trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250202006
Enrollment
136
Registered
2025-02-02
Start date
2025-05-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study focuses on the management of pain and distress during routine pediatric vaccinations in healthy children. Vaccination-related pain is a common concern that can lead to fear, anxiety, and long-term needle phobia in children, as well as increased stress for caregivers. Addressing this pain is essential to ensuring adherence to vaccination schedules and maintaining public health. The study evaluates a combined approach using a topical anesthetic cream (EMLA) and a cooling technique to

Interventions

Group A: Participants will receive 5% EMLA Cream (Eutectic Mixture of Local Anesthetics: Lidocaine 2.5% and Prilocaine 2.5%) as the standard treatment. Application Duration: Approximately 1 gram of EM
Active Comparator Procedure/Surgery,Experimental Procedure/Surgery
the standard treatment,Cooling group

Sponsors

Chulabhorn Royal Academy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 15 Years

Inclusion criteria

Inclusion criteria: The study population consists of pediatric patients aged 4 to 15 years receiving care at Chulabhorn Hospital Inclusion Criteria: 1.Children receiving a single dose of quadrivalent influenza vaccine on the day of their visit. 2.Parental consent to participate in the research.

Exclusion criteria

Exclusion criteria: 1.Diagnosed with G6PD deficiency. 2.Presence of rashes or wounds at the procedure site. 3.History of allergy to lidocaine or xylocaine. 4.Severe cardiac arrhythmia.

Design outcomes

Primary

MeasureTime frame
Pain levels with Wong-Baker FACES Pain Rating Scale 30 seconds after procedure scale

Secondary

MeasureTime frame
Parental satisfaction 15 minute after procedure scale,adverse effects 5 minute present,adverse effects 15 minute after procedure present,Pain levels with Wong-Baker FACES Pain Rating Scale 5 minute after procedure scale

Countries

Thailand

Contacts

Public ContactPaveewan Jiravisitkul

Chalabhorn Royal Academy

paveewan.jir@cra.ac.th66865682332

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026