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ketamine combination with propofol, dexmedetomidine or fentanyl for sedation in dressing in burn patients

Ketofol vs Ketodex vs Ketofen Sedation for Dressing in Burns in Adult Patients : A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044869
Enrollment
90
Registered
2022-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: T31- Burns classified according to extent of body surface involved Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Group KD: Group KD - Patients will receive KETODEX (Ketamine with dexmedetomidine), 0.5 µg/kg dexmedetomidine given as bolus over 5 min with ketamine 1mg/kg in the 5th minute. This will

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ASA 1-2 patients aged >18 years with burn injury having superficial to partial thickness burns scheduled for burn dressing.

Exclusion criteria

Exclusion criteria: a) Patients with any serious co-morbidities like cardiovascular disease, cerebrovascular disease , intracranial hypertension and respiratory tract infection b) Sinus bradycardia c) Deep burns or >50% burns d) History of substance abuse or dependence like alcohol e) Patients requiring mechanical ventilation f) Patients requiring vasopressor support g) Patients in the initial resuscitation phase h) Difficult airway i) History of serious adverse effects related to anaesthesia drugs like allergy j) Pregnancy k) History of seizures l) History of any neuropsychiatric disorder m) Patients on study drug infusion in last 12 hours

Design outcomes

Primary

MeasureTime frame
To compare the sedative and analgesic effects of Ketofol, Ketodex and Ketofen for dressing in burn patients by evaluating 1.NRS pain scores 2.Ramsay sedation score Timepoint: at the time of dressing

Secondary

MeasureTime frame
To evaluate the effect of Ketofol , Ketodex and Ketofen on 1. Hemodynamic profile (HR ,SBP , DBP ,MAP, Spo2, RR) 2. Satisfaction of the patient 3. Ease of dressing 4. Any adverse effects Timepoint: at the time of dressing

Countries

India

Contacts

Public ContactShailendra Kumar

AIIMS, New Delhi

drshail.kumar@gmail.com

Outcome results

None listed

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