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Clinical Trials/CTRI/2025/09/094087
CTRI/2025/09/094087Not yet recruitingNot Applicable

Comparison of 10 percent Lidocaine Spray versus 2.5 percent Lidocaine and 2.5 percent Prilocaine i.e.EMLA Cream for Attenuating Pain from Peripheral Venous Cannulation in Children: A Prospective Randomised Controlled Trial

Dr Shenaz Banu B1 site in 1 country126 target enrollmentStarted: September 12, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
126
Locations
1
Primary Endpoint
Pain during intravenous cannulation . Visual analogue scale score measured at the time of cannulation

Study Overview

Brief Summary

This study compares 10 percent lidocaine spray with EMLA cream made of 2.5 percent lidocaine and 2.5 percent prilocaine for reducing pain during intravenous cannulation in children aged 5 to 14 years undergoing elective surgeries. A total of 126 children will be randomly divided into two equal groups. One group will receive lidocaine spray and the other will receive EMLA cream before cannulation. The primary outcome is pain score measured using the visual analogue scale during cannulation. Secondary outcomes include heart rate changes before during and after cannulation, ease of cannulation, and local site reactions such as redness swelling and hardening at 20, 40 and 60 minutes after cannulation. The purpose of the study is to find out which topical anesthetic provides faster onset, better safety and more effective pain relief for children undergoing intravenous cannulation.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Investigator Blinded

Eligibility Criteria

Ages
5.00 Year(s) to 14.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children between 5 and 14 years undergoing elective procedures requiring anaesthesia American society of Anaesthesiologists (ASA) grade 1 and 2.

Exclusion Criteria

  • Children with difficult IV cannulation Emergency surgeries with burns, broken or infected skin Intellectual disabilities BMI above 85th percentile.

Outcomes

Primary Outcomes

Pain during intravenous cannulation . Visual analogue scale score measured at the time of cannulation

Time Frame: Pain score at the time of baseline - during the time of intravenous cannulation | and hemodynamic parameters measured five minutes before ,at the time of cannulation and five minutes after cannulation

Hemodynamic parameters like heart rate and oxygen saturation is measured

Time Frame: Pain score at the time of baseline - during the time of intravenous cannulation | and hemodynamic parameters measured five minutes before ,at the time of cannulation and five minutes after cannulation

Secondary Outcomes

  • Heart rate changes before, during, after), ease of cannulation, and local side effects(Twenty , forty and sixty minutes after the cannulation)

Investigators

Sponsor
Dr Shenaz Banu B
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Shenaz Banu

Sri Venkateshwaraa Medical College Hospital and Research Centre

Study Sites (1)

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