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Exploring the Efficacy of Ketamine Versus Fentanyl in Pain Management for Limb Injuries: A Randomized Controlled Trial

A Randomized Controlled Study for Comparison of Intravenous Low Dose Ketamine Versus Intravenous Fentanyl for Pain Management in Isolated Limb Injury Patients - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062489
Enrollment
110
Registered
2024-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: T149- Unspecified injury Health Condition 2: T07- Unspecified multiple injuries

Interventions

Intervention1: LOW DOSE KETAMINE FOR PATIENTS WITH ISOLATED LIMB INJURIES WITH VAS SCORE OF MORE THAN OR EQUAL TO 4 SELECTED RANDOMLY: LOW DOSE KETAMINE 0.3 mg/kg IV bolus push or slow infusion Interv

Sponsors

All India Institute of Medical SciencesAIIMSJodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: STUDY GROUP: Patients presenting to AIIMS emergency department with isolated Limb injuries INCLUSION CRITERIA: Age – 18-70 yrs with Moderate and Severe pain (VAS =4) and systolic blood pressure (SBP) of 90-180 mm of Hg

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA: 1. Threatened Airway 2. Chest injury 3. Neurovascular deficiency 4. Grade 3 and Grade 4 shock 5. Pregnancy 6. History of allergy to ketamine, fentanyl (or opioids) 7. History of liver disease 8. History of renal disease 9. History of heart disease 10.History of psychiatric illness 11.Inability to understand the VAS pain rating system

Design outcomes

Primary

MeasureTime frame
The Primary outcome measure of the study is decrease in the VAS score in the two groups (One group that received Ketamine & the other that received Fentanyl).Timepoint: 18 months

Secondary

MeasureTime frame
Secondary Objectives 1. Proportion of patients who need additional Rescue Medications for pain 2. Proportion of patients who need Rescue Medications for pain during minor procedures 3. Adverse reactions in the two groupsTimepoint: 18 months

Countries

India

Contacts

Public ContactMarina Kharkongor

All India Institute of Medical Sciences(AIIMS), Jodhpur

drnsemail@gmail.com9953771090

Outcome results

None listed

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