None listed
Conditions
Interventions
Intervention1: Exocool Pain Numbing Device: Exocool Pain Numbing Device to be used numb an area on the body while administering injection It takes about 4-6 seconds to numb sensitive skin and 8-10 sec
Sponsors
Camex Wellness Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Children age 4-18years 2 Subjects requires single immunization such as MMR 3 Subjects prescribed one or more category of drug for injection or cannulation. 4Subject is willing to provide the informed consent 5 Subject having not participated in a similar investigation in the past one month. 6 Subjects ready to follow instructions during the study period.
Exclusion criteria
Exclusion criteria: 1 Subjects skin is too resistant 2 Incomplete information of patients. 3 Subject having any allergic reaction to metal and cold sensation. 4 Confirmed needle phobia. 5 Child with haemophillia or bleeding disorder 6 Eczema/skin damage at injection site 7 Children with behavioural/developmental disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Pain using the VAS scale by patient and carerTimepoint: Day1, Day2 and Day7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Success or failure of the injection in the presence of complications, Satisfaction scores using Likert scale and whether they would use the device again will be assessedTimepoint: Day1, Day2 and Day7;To assess child WONG Baker Faces Scale scoreTimepoint: Day 1;To assess the adverse events immediate or delayed pain, erythema, sustained blanching, urticaria and pruritus in a 4 point scaleTimepoint: Day1, Day2 and Day7 | — |
Countries
India
Contacts
Public ContactRahul Chopra
Pharexcel Consulting Private Limited
Outcome results
None listed