None listed
Conditions
Brief summary
The primary purpose of this study is to compare the efficacy of PainEase and Angel for reducing pain associated with intravenous cannulation in children. The study hypothesis is that application of PainEase will reduce pain associated with drip insertion.We would be comparing PainEase with the current standard treatment of use of Angel for reducing pain associated with drip insertion.
Interventions
In this trial we would be applying a vapocoolant spray (PainEase) on the dorsum of the hands or cubital fossa of the children who would then undergo intravenous cannulation
The maximum number of times that this will be applied is four times and the least number of application would be once.The number of application of the product will be guided be successful intravenous cannulation and as stated the maximum number of application will be limited to four.
The mode of administration is that the prd
In this trial we would be applying a vapocoolant spray (PainEase) on the dorsum of the hands or cubital fossa of the children who would then undergo intravenous cannulation The maximum number of times that this will be applied is four times and the least number of application would be once.The number of application of the product will be guided be successful intravenous cannulation and as stated the maximum number of application will be limited to four. The mode of administration is that the prduct will be sprayed onto the skin of the dorsum of hand or the antecubital fossa(Topical). The dosage will be that the spray will be applied for maximum of 10 seconds at the selected site during one attempt of intravenous cannulation. The total duration of application at one site is 10 seconds and if cannulation is unsuccessful the next chosen site will be sprayed for maximum of 10 seconds.Overall the maximum total duration at four sites (if needed) will be 40 seconds.
Sponsors
Dr Benjamin D'Souza
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Healthy volunteers
No
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
Outcome results
None listed