None listed
Conditions
Interventions
None listed
Sponsors
DR CHHAVI ROSHA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Neonates who have completed 48 hours of life uneventfully post birth at the time of enrolment. 2. Neonates with a minimum weight of 2500 grams at the time of procedure. 3. Neonates born at or after 37 completed weeks of gestation. 4. Neonates free from major congenital abnormalities and are not on any life-support. 5. Neonates scheduled to undergo venipuncture for medical evaluation.
Exclusion criteria
Exclusion criteria: 1. Neonates with skin lesions, or dermatological disorders. 2. Neonates receiving any concurrent systemic medications, other than the nutritional supplements. 3. Neonates born to mothers with compromised immune systems or mothers found positive for any communicable or infectious disease. 4. Neonates currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study will be the assessment of Pain Perception experienced by the neonates during the venipuncture procedure. The pain scores obtained from the scales will be the primary outcome to determine the anaesthetic potential of Akarkarabha and Lavanga topical gel in reducing pain perception during venipuncture in neonates.Timepoint: All assessments will be conducted at the following time points: 1. Baseline, 2. during venipuncture, and 3. post-procedure (30 minutes after the venipuncture procedure). | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary outcome, this study seeks to evaluate the incidence of sequelae or adverse events such as inflammation, erythema, oedema, alterations in skin integrity, localized infections, ecchymosis, delayed wound healing, & scar formation attributable to venipuncture within a 24-hour window following the application of Akarkarabha & Lavanga Gel at the venipuncture site.Timepoint: Within a 24-hour window following the application of Akarkarabha & Lavanga Gel at the venipuncture site. | — |
Countries
India
Contacts
Public ContactDR RAHUL H GUJARATHI
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune
Outcome results
None listed