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A clinical trial to study the effect of two drugs, Ketamine and Dexmedetomidine in pediatric patients undergoing tonsillectomy.

Comparison of ketamine vs dexmedetomidine given prior to extubation for prevention of emergence agitation in pediatric patients undergoing tonsillectomy- A double blinded randomized control trial. - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076789
Enrollment
44
Registered
2024-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: J039- Acute tonsillitis, unspecified Health Condition 2: J039- Acute tonsillitis, unspecified

Interventions

Intervention1: Ketamine: Ketamine 0.5 mg/kg diluted up to 10 ml (i.v slow) and given 15 min prior to the end of surgery Control Intervention1: Dexmedetomidine: 0.3 mcg/kg Dexmedetomidine, diluted to

Sponsors

Heritage Institute of Medical SciencesNH BypassBhadwarvaranasiUttar PradeshIndia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged ranged between 6 and 18 years belonging to ASA grade I scheduled for elective tonsillectomy

Exclusion criteria

Exclusion criteria: 1) Children with Congenital anomalies, developmental problems, Inborn errors of metabolism, cerebral palsy, down syndrome. 2) Obese children with a risk of airway obstruction. 3) Patients with previous history of agitation after sevoflurane anesthesia and patients with respiratory distress of any cause. 4) Children with known allergy to any of the medications used. 5)Non willing patients. 6) Prolonged or any other complication during surgery

Design outcomes

Primary

MeasureTime frame
To Compare the efficacy of ketamine (0.5mg/kg) vs dexmedetomidine (0.3mcg/kg) for prevention of emergence agitation using PAED scaleTimepoint: Immediately after emergence and at 10-minute,20-minute and 30-minute.

Secondary

MeasureTime frame
To assess pain intensity using FLACC scale(After extubation ,10 minute,20 minute & 30 minute). Compare the hemodynamic stability (heart rate, blood pressure, oxygen saturation & respiratory rate) during emergence & postoperative period. Timepoint: AT IMIIEDIATELY AFTER EMERGENCE, 10 Min,20 Min & 30 min.

Countries

India

Contacts

Public ContactDr Anil Kumar

Heritage Institute of Medical Sciences,Varanasi

aryanindia2003@yahoo.com8888832631

Outcome results

None listed

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