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To study and compare possibility of child being inconsolable after intranasal dexmedetomidine vs ketamine in children undergoing lower abdominal surgeries under desflurane anaesthesia with caudal block

Comparison of intranasal dexmedetomidine versus ketamine on prevention of desflurane induced emergence agitation in Pediatric patients undergoing lower abdominal surgery - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065559
Enrollment
80
Registered
2024-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

None listed

Interventions

Intervention1: Intranasal dexmedetomidine 1mcg/kg: 1mcg/kg Intervention2: Intranasal ketamine: 5mg/kg Control Intervention1: Dexmedetomidine: 0.1 microgram/kg intranasally, once preoperatively, 15 min

Sponsors

Dr Shikha Jain
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: undergoing elective lower abdominal surgery under caudal block.

Exclusion criteria

Exclusion criteria: History of mental disorders,seizures, Developmental delay, known endocrine disease, recent upper respiratory tract infections, known adverse effects to dexmedetomidine and ketamine

Design outcomes

Primary

MeasureTime frame
Incidence of Emergence agitation after premedication with intranasal dexmedetomidine 1mcg/kg versus intranasal ketamine 5mg/kg calculated by PAEDS scale ( Score of 12 indicating no agitation, 12, indicating agitation)Timepoint: At baseline, 15 minutes,30 minutes, 45 minutes 1 hour, 4 hour, 6 hour, 12 hour, 24 hour

Secondary

MeasureTime frame
To determine and compare mask acceptance scores amongst both groups during induction.Timepoint: At induction of anaesthesia;Incidence of postoperative pain after premedication with intranasal dexmedetomidine 1mcg/kg versus intranasal ketamine 5mg/kg, calculated by FLACCscore groups at extubation and every 15 minute till 1 hr, 4hr, 6hr, 12hr, 24hr.Timepoint: at extubation and every 15 minute till 1 hr, 4hr, 6hr, 12hr, 24hr.;determine and compare hemodynamic parameters and side effects- number of episodes of postoperative nausea and vomiting (PONV), laryngospasm, coughing, salivation, breath holding after intranasal dexmedetomidine and intranasal ketamine Timepoint: Post extubation, every 15 minutes till 1 hour and every 30 minutes the next hour.

Countries

India

Contacts

Public ContactDr Shikha Jain

Aiims bhopal

itzshikhahere@gmail.com7987164388

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026