Evaluating Stress Response and Anxiety Score in Paediatric Patients

NCT04526652 | Completed Phase 2 DMC

• 1 other identifier: A82010307
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 serum cortisol levels with perioperative dialogue intervention.There have been a number of studies done on adult patients indicating that dexmedetomidine was indeed capable of reducing level of anxiety with evidence of lower serum cortisol levels. Hence, we postulated that intranasal dexmedetomidine administration in pediatric patients will lower the serum cortisol levels but we need to evaluate the extent of reduction.

Conditions

Anxiety and Fear; Anesthesia

Keywords

Paediatric; Intranasal; General anaesthesia; Dexmedetomidine; Anxiety score; cortisol

Outcome Measures

Primary Outcomes (2)

• Evaluating stress response

  Evaluating stress response by measuring serum cortisol level (nmol/L)

  Baseline: (before giving study drugs) and 1 to half an hour after drugs given

• Evaluating anxiety score

  To compare mean anxiety score using modified Yale Preoperative Anxiety Scales (m-YPAS)

  Baseline:(before giving study drugs) and 1 to half an hour after drugs given

Secondary Outcomes (3)

• Safety profile of Intranasal Dexmedetomidine in paediatric patients

  Baseline and 10 minutes interval after study drugs given

• Safety profile of Intranasal Dexmedetomidine in paediatric patients

  Baseline and 10 minutes interval after study drugs given

• Safety profile of Intranasal Dexmedetomidine in paediatric patients

  Baseline and 10 minutes interval after study drugs given

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Intranasal dexmedetomidine 1mcg/kg

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Intranasal normal saline equivalent to (1mcg/kg dose of dexmedetomidine)

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Evaluating anxiety score in both arms

Dexmedetomidine

Placebo DRUG

Evaluating anxiety score in both arms

Placebo

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 15200, Malaysia

Location

Related Publications (5)

• Isik B, Arslan M, Tunga AD, Kurtipek O. Dexmedetomidine decreases emergence agitation in pediatric patients after sevoflurane anesthesia without surgery. Paediatr Anaesth. 2006 Jul;16(7):748-53. doi: 10.1111/j.1460-9592.2006.01845.x.

  PMID: 16879517 BACKGROUND

• Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.

  PMID: 10702460 BACKGROUND

• Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.

  PMID: 22950484 BACKGROUND

• Yuen VM, Hui TW, Irwin MG, Yao TJ, Wong GL, Yuen MK. Optimal timing for the administration of intranasal dexmedetomidine for premedication in children. Anaesthesia. 2010 Sep;65(9):922-9. doi: 10.1111/j.1365-2044.2010.06453.x.

  PMID: 20645951 BACKGROUND

• Akin A, Bayram A, Esmaoglu A, Tosun Z, Aksu R, Altuntas R, Boyaci A. Dexmedetomidine vs midazolam for premedication of pediatric patients undergoing anesthesia. Paediatr Anaesth. 2012 Sep;22(9):871-6. doi: 10.1111/j.1460-9592.2012.03802.x. Epub 2012 Jan 23.

  PMID: 22268591 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Huda Zainal Abidin, MD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and Anaesthetist

Model Details: Randomization of paediatric patients for general anaesthesia one arm: Intranasal dexmedetomidine another arm: Intranasal normal saline (placebo)

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 26, 2020
• Study Start: December 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: August 1, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)