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Comparison of 2 pain killers - Ketamine administered through a nebulization mask versus Lornoxicam administered through an intravenous cannula - for pain management in patients with abdominal pain due to kidney stones

Comparison of Inhalational Ketamine and Intravenous NSAID for analgesia in patients with acute renal colic in the Emergency Medicine - A Randomized Control Study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097726
Enrollment
200
Registered
2025-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: N200- Calculus of kidney Health Condition 2: N202- Calculus of kidney with calculus of ureter Health Condition 3: N201- Calculus of ureter

Interventions

Intervention1: Nebulized Ketamine: Ketamine 1mg/kg given over 15 mins and reassess after every 15 mins for 1 hour Control Intervention1: Intravenous Lornoxicam: IV Lornoxicam 8mg Infusion over 15 min

Sponsors

Department of Emergency Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of age 18-65 years presenting with acute renal colic pain to the Emergency Department 2.Confirmed or highly suspected renal colic diagnosis (based on clinical presentation with or without imaging). 3.Pain score less than or equal to 5 on a 0 to 10 numerical rating scale 4.Warranted use of ketamine or NSAIDs as determined by treating physician 5.Patients had to be awake, alert, and oriented to person, place, and time

Exclusion criteria

Exclusion criteria: 1.Imaging or Investigations indicating no renal or ureteric calculi 2.Known hypersensitivity to Ketamine or IV NSAIDS 3.Patients who received analgesics within 4 hours prior to ED arrival 4.Conditions where ketamine or NSAIDs are contraindicated GI bleeding, AKI, CKD, Psychosis, CAD, CLD 5.Unstable vital signs (SBP less than 90 mm Hg or more than 180 mm Hg, Pulse less than 50 bpm or more than 150 bpm, or RR less than 10 or more than 30 bpm) 6.Conditions where peritoneal inflammation is suspected 7.Patients who are pregnant or breastfeeding 8.Patients with altered mental status and unable to give consent

Design outcomes

Primary

MeasureTime frame
To compare pain reduction after administration of nebulized Ketamine with that of intravenous Lornoxicam in patients with renal colic, measured using Numerical Rating ScaleTimepoint: 15, 30, 45 and 60 minutes

Secondary

MeasureTime frame
To observe time to significant pain relief (NRS fall more than or equal to 3)Timepoint: Reassessed at 15, 30, 45 and 60 minutes;To assess the need for rescue analgesia using a strong opioid (IV Fentanyl)Timepoint: Assessed at 15, 30, 45 and 60 minutes;To study acute adverse effect profile of both drugsTimepoint: ;To assess the level of Patient satisfaction (using 5 point Likert scale)Timepoint:

Countries

India

Contacts

Public ContactDr. Nisanth Menon N

Malankara Orthodox Syrian Church Medical College Hospital

emed@moscmm.org9447701890

Outcome results

None listed

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