Pain Ease spray vs. Angel cream for drip insertion in childre

Phase 2

• Conditions: Reduction of pain associated with IV cannulation in children; Anaesthesiology - Pain management

• Registration Number: ACTRN12609000796280
• Lead Sponsor: Dr Benjamin D'Souza

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Children between 6 and 18 yrs of age, presenting to the pediatric emergency department(PED) and requiring IV cannulation

Exclusion Criteria

Patients requiring urgent vascular access
Patients with impaired consciousness, a history of psychiatric illness or with developmental delay
Use of opioid analgesics or sedating agents within 4 hours of enrollment
Patients with pain score of greater than 6 (Pain Scale 0-10), i.e. requiring urgent analgesia
In patients with Diabetes Mellitus or patients with Cold hypersensitivity as Pain Ease is specifically contraindicated in these groups.
Sensitivity or previous adverse reactions to halogenated hydrocarbons or amethocaine
Non English speaking families
Those unable to understand the study protocol or the Visual Analog scale

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aim is to primarily evaluate the effectiveness of PainEase compared to AnGel in reducing the pain associated with IV cannulation[Pain score 1 min after successful IV cannulation(Child,doctor,nurse and parent).The child's face will be video recorded and two independent doctors will be assigning pain score using the same scale.These doctors will be unaware of the product applied to the child.]

Secondary Outcome Measures

Name	Time	Method
Difficulty in identifying vein after application of either product.<br>This will be assesed by the treating doctor using a 5 point scale (extremely easy to extremely difficult)[This assessment will be made just prior to cannulation];Evaluate the effect of use of AnGel or PainEase on cannulation success rate.<br>This outcome will be assessed based on the number of attempts needed for achieving suucessful intravenous cannulation when using either products which will be recorded on the study data collection sheet.[Number of IV cannulation attempts and time required to acheive successful IV cannulation];Adverse events secondary to application of either product.<br>This will be recorded by the treating doctor on the study data collection sheet and reviewed by local adverse event monitoring committee.[This will be assesed immidiately after application of product, before the child is discharged and follow up phone call 2 days after discharge.]