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Role of syrup mefenamic acid or syrup paracetamol in preventing pain associated with vaccination in children

Efficacy of oral mefenamic acid, paracetamol and placebo for analgesic prophylaxis in childhood vaccination: A three arm, parallel, triple-blind Randomized Controlled Trial - MAP VaC Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030239
Enrollment
90
Registered
2021-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

None listed

Interventions

Intervention1: syp. Mefenamic Acid: 4mg/kg dose stat 30 minutes prior to vaccination Control Intervention1: Placebo: 4mg/kg dose stat 30 minutes prior to vaccination Control Intervention2: Syp Paracet

Sponsors

Dr Rachna Pasi
Lead Sponsor
Dr Arun Babu T
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Children who will be coming for routine vaccination as per National immunization schedule and whose parents will give written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1.All children whose parents will not give consent to participate. 2.Children who will be having any liver or kidney diseases and coagulation disorders. 3.Children with past history of any allergic reactions. 4.Children in whom pain assessment could not be satisfactorily done

Design outcomes

Primary

MeasureTime frame
To assess the effect of mefenamic acid or paracetamol as prophylactic analgesic in pain management in children during vaccination using FLACC scale.Timepoint: At time of vaccination 15 minutes after vaccination 30 minutes after vaccination

Secondary

MeasureTime frame
To assess the effect of mefenamic acid or paracetamol on systemic symptoms after vaccinationTimepoint: 24 hours after vaccination

Countries

India

Contacts

Public ContactDr Arun Babu T

AIIMS, Mangalagiri

rachna.pasi@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026