Will Topical pain numbing device cause analgesia during routine immunization in children? A double blinded randomized controlled trial.

Efficacy of Non Invasive Topical Pain Numbing Device for Prophylactic Analgesia During Routine Vaccination in Children. A Double Blinded Randomized Controlled Trial (PAVAC Trial) - NIV-PAVAC Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083734

Enrollment

100

Registered

2025-03-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

None listed

Interventions

Intervention1: Topical pain numbing device: Topical pain numbing device has a metal tip, works under principle of cryoanalgesia. It cools and numbs the site of application, there by decreasing pain Co

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 6weeks to 10yrs attending pediatric OPD for routine immunization and whose parents will give written informed consent to participate in study.

Exclusion criteria

Exclusion criteria: 1.Children with any known chronic diseases of heart, liver, kidney. 2.Any neurologic disease. 3.Coagulation disorder 4.Past h/o any allergic reactions/ AEFI 5.Child received oral/ parenteral analgesics in last 3days. 6.Children whose parents did not give consent to participate in study.

Design outcomes

Primary

Measure	Time frame
1.To study efficacy of pain numbing device during routine childhood immunization by assessing FLACC score Timepoint: 1. Outcome is assessed by FLACC score done at 0, 5 and 15 mins after vaccination.	—

Secondary

Measure	Time frame
To study safety, toleralibity of pain numbing device during routine childhood immunizationTimepoint: Children is observed(followed) for 24hrs after vaccination.	—

Countries

India

Contacts

Public ContactT Arun Babu

AIIMS Mangalagiri

swethamadhuripulla666@gmail.com9121197609

Outcome results