Assessing the efficacy of Ketamine and Profopol mixed together in a single syringe to sedate or reduce pain during a procedure in the Emergency Department

â??KETOFOLâ?? â?? A combination of Ketamine and Propofol for Procedural Sedation & Analgesia in Emergency Department (ED) â?? A prospective observational study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/010271

Enrollment

Registered

2017-10-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- All trauma patients, between 18 and 60 years of age, with a visual analog scale pain score of more than or equal to 6/10, and require a procedural sedation and analgesia.

Interventions

Intervention1: Ketamine, Propofol (KETOFOL): Ketamine, a phencyclidine derivative, produces dissociative sedation and provides both analgesia and amnesia. Although it causes minimal cardiovascular or

and sedation (for spinal anesthesia). One reason for favoring this combination is their opposing respiratory and hemodynamic effects. In addition, Ketamine and Propofol have complementary effects. Thi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >18 yrs to 2. For whom the treating physician selected KETOFOL for procedural sedation and analgesia 3. Visual Analog Scale pain score of > 6/10

Exclusion criteria

Exclusion criteria: 1. Hemodynamically unstable patients 2. Patients with respiratory compromise 3. Suspicion of head injury or raised ICP 4. Presence of psychiatric history 5. Chronic respiratory, renal or hepatic failure 6. Pregnant patients 7. Documented allergy to propofol or ketamine 8. Inability to understand VAS pain score 9. Not willing to give a written consent

Design outcomes

Primary

Measure	Time frame
Procedural sedation and analgesia with ketofol was considered efficacious if the required procedure was completed and no adjunctive medications were required. Efficacy was measured using the Visual analog scale (VAS).Timepoint: Visual analog scale (VAS) pain score was assessed at the time of presentation to Emergency department, before the procedure and study drug administration, during the procedure and after the procedure.	—

Measure

Time frame

Procedural sedation and analgesia with ketofol was considered efficacious if the required procedure was completed and no adjunctive medications were required. Efficacy was measured using the Visual analog scale (VAS).Timepoint: Visual analog scale (VAS) pain score was assessed at the time of presentation to Emergency department, before the procedure and study drug administration, during the procedure and after the procedure.

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Secondary

Measure	Time frame
Safety of the drug was assessed by monitoring the vitals signs and looking for any adverse events. Satisfaction ratings and Recovery time will be notedTimepoint: Vital sign changes were noted as the maximum variation recorded during the procedure or recovery period compared with pre-procedural levels. Satisfaction rating recorded at time of discharge. Recovery time is calculated from the last dose of medication given until discharge criteria are met.	—

Measure

Time frame

Safety of the drug was assessed by monitoring the vitals signs and looking for any adverse events. Satisfaction ratings and Recovery time will be notedTimepoint: Vital sign changes were noted as the maximum variation recorded during the procedure or recovery period compared with pre-procedural levels. Satisfaction rating recorded at time of discharge. Recovery time is calculated from the last dose of medication given until discharge criteria are met.

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Countries

India

Contacts

Public ContactSriihari Cattamanchi

Sri Ramachandra Medical College & Research Institute

srihari@cattamanchi.in919994616329

Outcome results

None listed

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