Comparison of intravenous drugs like Nalbuphine, Ketamine and Dexmedetomidine for the prevention of a state of confusion and restlessness that can occur in children after waking up from general anesthesia who were posted for adenotonsillectomy

Effectiveness of low dose intravenous dexmedetomidine,ketamine and nalbuphine in preventing emergence agitation after sevoflurane anaesthesia in children undergoing Adenotonsillectomy, A randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/078947

Enrollment

Registered

2025-01-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Emergence agitation: PAED score FLACC score PACU score Control Intervention1: Group A patients will receive Inj Dexmedetomidine: Group A patient will be receaving low dose 0.25mcg/kg of

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and II Age 3 to 10 years weight 15 to 35 kg Duration of procedure 60 to 90 minutes

Exclusion criteria

Exclusion criteria: Physical developmental delay Consent refusal from parents Bleeding disorders

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of low dose intravenous Dexmedetomidine, Ketamine and Nalbuphine in preventing emergence agitation by assessing pediatric anesthesia emergence delirium (PAED) score after extubation in postoperative period.Timepoint: 4 hours	—

Secondary

Measure	Time frame
To monitor hemodynamics intraoperatively , at extubation and postoperatively.Timepoint: 15 minutes;To measure and compare sedation post operatively using Ramsay Sedation scaleTimepoint: 10 minutes 20 minutes 30 minutes;To assess post operative Analgesic effect using Face, Leg, Activity, Cry and Consolability (FLACC) scaleTimepoint: 10 minutes 20 minutes 30 minutes;To observe complications like postoperative nausea and vomiting, Bradycardia, Coughing, LaryngospasmTimepoint: 4 hours	—

Measure

Time frame

To monitor hemodynamics intraoperatively , at extubation and postoperatively.Timepoint: 15 minutes;To measure and compare sedation post operatively using Ramsay Sedation scaleTimepoint: 10 minutes 20 minutes 30 minutes;To assess post operative Analgesic effect using Face, Leg, Activity, Cry and Consolability (FLACC) scaleTimepoint: 10 minutes 20 minutes 30 minutes;To observe complications like postoperative nausea and vomiting, Bradycardia, Coughing, LaryngospasmTimepoint: 4 hours

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Countries

India

Contacts

Public ContactDr C Rajesh Prabhu

Aarupadai veedu medical college and hospital

vallijegan@gmail.com9940882722

Outcome results

None listed

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