| CTRI Number |
CTRI/2025/11/097726 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
Comparison of Inhalational Ketamine and Intravenous NSAID for analgesia in patients with acute renal colic in the Emergency Medicine - A Randomized Control Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Aasif K Nazar |
| Designation |
1st year DNB Resident |
| Affiliation |
Malankara Orthodox Syrian Church Medical College Hospital |
| Address |
Emergency medicine department,
Malankara Orthodox Syrian Church Medical College Hospital,
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9495633774 |
| Fax |
|
| Email |
aasifknazar001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nisanth Menon N |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Malankara Orthodox Syrian Church Medical College Hospital |
| Address |
Emergency medicine department,
Malankara Orthodox Syrian Church Medical College Hospital,
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9447701890 |
| Fax |
|
| Email |
emed@moscmm.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nisanth Menon N |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Malankara Orthodox Syrian Church Medical College Hospital |
| Address |
Emergency medicine department,
Malankara Orthodox Syrian Church Medical College Hospital,
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9447701890 |
| Fax |
|
| Email |
emed@moscmm.org |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine
Malankara Orthodox Syrian Church Medical College Hospital,
Kolenchery,
Ernakulam,
Kerala,
India,
Pincode - 682311 |
|
|
Primary Sponsor
|
| Name |
Department of Emergency Medicine |
| Address |
Malankara Orthodox Syrian Church Medical College Hospital,
Kolenchery,
Ernakulam,
Kerala,
India
Pincode - 682311 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aasif K Nazar |
Malankara Orthodox Syrian Church Medical College Hospital, Kolenchery |
Yellow Zone,
Emergency Medicine Department
Ernakulam
KERALA |
9447304713
aasifknazar001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Malankara Orthodox Syrian Church Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (3) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Lornoxicam |
IV Lornoxicam 8mg Infusion over 15 mins and reassess after every 15 mins for 1 hour |
| Intervention |
Nebulized Ketamine |
Ketamine 1mg/kg given over 15 mins and reassess after every 15 mins for 1 hour
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare pain reduction after administration of nebulized Ketamine with that of intravenous Lornoxicam in patients with renal colic, measured using Numerical Rating Scale |
15, 30, 45 and 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe time to significant pain relief (NRS fall more than or equal to 3) |
Reassessed at 15, 30, 45 and 60 minutes |
| To assess the need for rescue analgesia using a strong opioid (IV Fentanyl) |
Assessed at 15, 30, 45 and 60 minutes |
| To study acute adverse effect profile of both drugs |
|
| To assess the level of Patient satisfaction (using 5 point Likert scale) |
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2027 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group,active controlled trial comparing inhalation ketamine and intravenous NSAID for analgesia in 200 patients with acute renal colic that will be conducted in a single centre in India. The primary outcome measures will be to compare pain reduction after administration of Nebulized Ketamine with that of IV Lornoxicam in patients suspected with renal colic, measured using NRS at 15, 30, 45 and 60 minutes. The secondary outcomes will be to observe time to significant pain relief, to assess need for rescue analgesia, to study incidence of adverse effects of both drugs and to assess the level of Patient satisfaction (on a score of 1-5). |