Clinical trial to study the comparison of two doses of nebulised dexmedetomidine in paediatric patients

Phase 4

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/04/042068
• Lead Sponsor: gopal krishan jalwal

Brief Summary

premedication is defined as the administration of medication before induction of anaesthesia. The drugs are given to reduce anxiety, secretions, pain and as prophylaxis for nausea and vomiting. In paediatric patients, premedication assumes increased importance because several factors may contribute to heightened anxiety, such as fear of separation from patients, fear of an unfamiliar environment and of needle pricks. nebulised dexmedetomidine is a prudent choice for premedication in the pediatric age group because of its sedative, anxiolytic, hypnotic, analgesic and sympatholytic effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patient of either sex in the age group of 3 to 8 years belong to ASA 1 or II 2.
• Patient scheduled for elective infraumblical and lower limb surgeries under general anaesthesia with endotracheal intubation.

Exclusion Criteria

• Patient with history of cardiac disease, asthma, seizure disorders, mental retardation, developmental delay, prematurity and allergy will be excluded from the study 2.
• Surgeries performed under general anaesthesia using supraglottic airway device.
• Emergency surgeries.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of two doses of nebulised dexmedetomidine as premedication in paediatric patients for parental separation anxiety	patient separation anxiety scale will be assessed while shifting the patient to OT | time point : 24 weeks

Secondary Outcome Measures

Name	Time	Method
1) To compare Mask acceptance score, sedation score, haemodynamic variables, emergence scores	6 months

Trial Locations

Locations (1)

AIIMS, Bathinda; 🇮🇳 Bathinda, PUNJAB, India

AIIMS, Bathinda

🇮🇳Bathinda, PUNJAB, India

gopal krishan jalwal

Principal investigator

7838939833

gopaljalwal@gmail.com