Comparing the effect of drug combinations Dexmedetomidine and ketamine with midazolam and ketamine through intranasal route in children to make them calm and comfortable before surgery.

Comparison of premedication with intranasal dexmedetomidine and ketamine combination with midazolam and ketamine combination in children - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071944

Enrollment

Registered

2024-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: dexmedetomidine and ketamine: Dose- dexmedetomidine- 1mcg/kg. Ketamine- 2mcg/kg. Frequency - once before surgery Route intranasal Duration- 30 to 60 minutes Cont

Eligibility

Inclusion criteria

Inclusion criteria: All patients of age between2 to 6 years belonging to ASA 1 undergoing elective surgery under general Anaesthesia with supraglottic wirway device or endo tracheal tube

Exclusion criteria

Exclusion criteria: 1.Active upper respiratory tract infection 2.Patients with known allergy to study drug 3.Patients at risk for airway obstruction 4.Patients with neurodevelopmental delay

Design outcomes

Primary

Measure	Time frame
To compare ease of parental separation in children undergoing elective surgery by premedication with intranasal combinations dexmedetomidine and ketamine combination with intranasal midazolam and ketamine.Timepoint: Parental separation assesed onceat (30-60) minutes Post drug intervention	—

Secondary

Measure	Time frame
To assess 1. Preoperative sedation using 4 point sedation scale 2. Mask acceptance using mask acceptance scale 3. Emergence delirium after waking up using emergence agitation scale 4. Post operative analgesia using FLACC scale 5. Recovery profileTimepoint: 1.Preoperative sedation will be measured once at baseline preoperatively. 2.Mask acceptance scale measured once at baseline during induction. 3.FLACC scale measured postoperative at base line ,15 minutes, 30 minutes, 45 minutes, 60 minutes 4.Emergence agitation scale measured postoperative at baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes 5.Recovery profile once postoperatively	—

Measure

Time frame

To assess 1. Preoperative sedation using 4 point sedation scale 2. Mask acceptance using mask acceptance scale 3. Emergence delirium after waking up using emergence agitation scale 4. Post operative analgesia using FLACC scale 5. Recovery profileTimepoint: 1.Preoperative sedation will be measured once at baseline preoperatively. 2.Mask acceptance scale measured once at baseline during induction. 3.FLACC scale measured postoperative at base line ,15 minutes, 30 minutes, 45 minutes, 60 minutes 4.Emergence agitation scale measured postoperative at baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes 5.Recovery profile once postoperatively

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Countries

India

Contacts

Public ContactJeetendra Kumar bajaj

Vardhan Mahavir medical college and Safdarjung hospital

Jeetendrabajaj@gmail.com9810465070

Outcome results