| CTRI Number |
CTRI/2021/01/030239 [Registered on: 05/01/2021] Trial Registered Prospectively |
| Last Modified On: |
12/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of syrup mefenamic acid or syrup paracetamol in preventing pain associated with vaccination in children |
|
Scientific Title of Study
|
Efficacy of oral mefenamic acid, paracetamol and placebo for analgesic prophylaxis in childhood vaccination: A three arm, parallel, triple-blind Randomized Controlled Trial |
| Trial Acronym |
MAP VaC Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachna Pasi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
Room no 307, Department of Pediatrics, Pediatric division, All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
|
| Fax |
|
| Email |
rachna.pasi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachna Pasi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
rom no 307, Department of Pediatrics, Pediatric Division, All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
|
| Fax |
|
| Email |
rachna.pasi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Babu T |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
Room no 309, Department of Pediatrics, Pediatric Division, All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
|
| Fax |
|
| Email |
babuarun@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rachna Pasi |
| Address |
Department of Pediatrics, AIIMS, Mangalagiri |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Arun Babu T |
Department Of Pediatrics, AIIMS, Mangalagiri |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rachna Pasi |
AIIMS, Mangalgiri |
Department of Pediatrics, Pediatric Division, Room no 307/309
Guntur
ANDHRA PRADESH |
9494902674
rachna.pasi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Mangalagiri Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children receiving vaccination |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
4mg/kg dose stat 30 minutes prior to vaccination |
| Comparator Agent |
Syp Paracetamol |
15mg/kg/dose stat 30 minutes prior to vaccination |
| Intervention |
syp. Mefenamic Acid |
4mg/kg dose stat 30 minutes prior to vaccination |
|
|
Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of mefenamic acid or paracetamol as prophylactic analgesic in pain management in children during vaccination using FLACC scale. |
At time of vaccination
15 minutes after vaccination
30 minutes after vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of mefenamic acid or paracetamol on systemic symptoms after vaccination |
24 hours after vaccination |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "135"
Final Enrollment numbers achieved (India)="135" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2021 |
| Date of Study Completion (India) |
30/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Publication will be done in scientific journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Immunization is a crucial part of disease prevention in childhood which is having a long-term positive impact. Immunization is also accompanied by fear of getting vaccinated with needles and associated pain with it. Pain is usually underrated for pediatric population. Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAIDs). NSAIDs are most effective and commonly used analgesic for acute pain. it is widely used anti-pyretic, anti-analgesic and anti-inflammatory drug in children. The Face Leg Activity Cry Consolability (FLACC) scale has five parameters to look for face, leg, activity, cry, consolability. Each of these parameters are ranked on three point scale(0-2) as per response severity and together all scores add up to 0-10. It is valid, reliable and easy to administer scale for post- procedural pain measurement in children from 2 months to 7 years of age. Although mefenamic acid and other NSAIDs like paracetamol is very frequently prescribed as analgesic and anti-pyretic post-vaccination but there is no published study for use of mefenamic acid as prophylactic analgesic for vaccination procedural pain. so this study is planned to find out the role of mefenamic acid as prophylaxis for analgesia during vaccination. It is a randomized controlled triple blind trial. Aim: To study the efficacy of mefenamic acid as analgesic prophylaxis in pain management in children during vaccination. The participants in both groups will be enrolled by block randomization list generated by computer randomization software. Drug and placebo in both groups will be coded as A/B having similar physical properties. Each participant will be given drug as per their allocation. Vaccination as per National Immunization Schedule will be given to participants 30 minutes after drug administrated. FLACC scoring will be done during and 30 minutes after vaccination administration by the same person. Person who will be doing intervention, administrating drug, vaccinating, scoring and statistician all will be blinded. Concealment will be disclosed after results will have been locked. |