Status:
COMPLETED
Evaluating Stress Response and Anxiety Score in Paediatric Patients
Lead Sponsor:
Universiti Sains Malaysia
Conditions:
Anxiety and Fear
Anesthesia
Eligibility:
All Genders
1-12 years
Phase:
PHASE2
Brief Summary
To date, there have been no studies done relating serum cortisol levels and intranasal dexmedetomidine sedation. However, there was a behavioral study done on pediatric patients confirming reduction s...
Detailed Description
Justification of study With increase in number of pediatric patients undergoing surgery, efforts need to be placed on improving quality of perioperative care and patient comfort Intranasal administra...
Eligibility Criteria
Inclusion
- Pediatric patients age 1-12 years old
- Weight of patient between 10 - 60 kgs
- American Society of Anesthesiologist (ASA) I or II
- Scheduled for elective and emergency surgeries
- Caregivers able to understand and provide informed consent
Exclusion
- Allergy to study drugs (dexmedetomidine, morphine, paracetamol etc.)
- Special need Children (Cerebral palsy, down syndrome, ADHD, ASD)
- Serious cardiac/respiratory diseases.
- Children with neuromuscular disorders or neurological diseases (epilepsy etc)
- Children with Metabolic disorders
- Difficult airway cases
- Children on any kind of steroid therapy / HPA diseases
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04526652
Start Date
December 1 2020
End Date
August 1 2021
Last Update
October 25 2021
Active Locations (1)
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1
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia, 15200