TOPICAL LOCAL ANAESTHETIC SPRAY WITH VAPOCOOLANT VERSUS EMLA CREAM IN INFANTS DURING VACCINATION

Completed

Conditions: Came for Routine Immunization

Registration Number: CTRI/2021/05/033426

Lead Sponsor: DR AYUSH JAIN

Brief Summary: **SUMMARY**

The study was an open-label three-arm, randomized controlledtrial which was done in KLES Dr Prabhakar Kore Hospital and Medical ResearchCentre, Belagavi and Rukmini Nagar Urban Health Centre, Belagavi from September2020 to September 2021. The study objective was to compare the pain reductionefficacy of topical local anesthetic spray with vapocoolant and EMLA cream duringimmunization. 228 children between the age of 9 and 11 weeks who were broughtfor immunization with 2nd dose of liquid pentavalent vaccine wereenrolled for the study. They were randomized to three groups according to the randomnumber table and were subjected to the assigned intervention.

They were subjected to Modified Behavioral Pain Scale bythe observer to assess the pain experienced by the infant before the injection,after 1 minute, and after 5 minutes of injection. The 10-point MBPS assesses 3 behavioral components (facial expression,movements, and cry) as an indication of a childâ€™s experience of pain. The total score is the sum of scores in each parameter. The maximumscore of 10 indicates the worst pain experience and the least possible score of 0indicates no pain. Parents also recorded their interpretation ofpain experienced by their children using the Visual Analog Scale which is a validated, subjective measure on a 10-pointscale for acute pain where zero is designated as â€œno painâ€ and 10 theâ€œworst possible painâ€.

It was observed that the post-injection MBPS pain scoreswere significantly low in the two intervention groups when compared to the control.The mean MBPS score at 1 minute wasleast in the group using the topical local anesthetic spray with vapocoolant(5.11Â±1.1) followed by the EMLA group (6.22Â±1.14) whereas the control group (7.62Â±0.89)exhibited the maximum pain score values. The same trend when also observedwhen parental VAS scores were compared. The mean VAS score is least in the group using the topical local anestheticspray with vapocoolant (3.66Â±1.66) followed by the EMLA group (4.5Â±1.31) whereas the control group (5.82Â±2.56) exhibited themaximum pain score values as per parents.

We also observed that the parents were good at predictingpain in their children as the parental VAS scores correlated clinically to theMBPS scores and the order of pain scores obtained across each interventiongroup is same, which is maximum in the control group and least in the group subjectedto LA spray. There was no difference in pain scores with respect to genderobserved.

The study proves that LA spray is beneficial in reducinginjection pain during vaccination of infants and can potentially be used inimmunization clinics conveniently, easily, and cost-effectively.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 228

Inclusion Criteria

All healthy infants of age group 9-11 weeks brought for immunization with 2nd dose of Liquid Pentavalent Vaccine.

Exclusion Criteria

1)Infants with any painful lesion or condition 2)Infants receiving treatment with methaemoglobin-inducing agents 3)Infants on medications which can alter pain perception and response 4)Neurologically depressed infants due to any condition 5)Severe allergic reaction to a vaccine component or following a prior dose of a vaccine 6)History of reaction following application of topical anaesthetic agent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the pain reduction efficacy of the topical local anaesthetic spray with vapocoolant and EMLA cream during vaccination to children	0 minute, 1 minute and 5 minutes after injection

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (2): KLES DR. PRABHAKAR KORE HOSPITAL AND MRC
🇮🇳
Belgaum, KARNATAKA, India
RUKMINI NAGAR UHC
🇮🇳
Belgaum, KARNATAKA, India
KLES DR. PRABHAKAR KORE HOSPITAL AND MRC
🇮🇳Belgaum, KARNATAKA, India
DR AYUSH JAIN
Principal investigator
9971072014
ajain1994@gmail.com