| CTRI Number |
CTRI/2026/04/108321 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
12/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in comparing 2 pain relief medication in patients with kidney stone. |
|
Scientific Title of Study
|
To determine the efficacy and safety of intravenous Ketorolac tromethamine versus Tramadol in adults with acute renal colic presenting to the emergency department: A randomized controlled trial-single blinded. |
| 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 R Kaveri |
| Designation |
PG Register |
| Affiliation |
Christian medical college Vellore-632004 |
| Address |
Christian Medical College Vellore - 632004
Department of emergency medicine. Emergency building Room no.1 and D001.
Christian Medical College Vellore-632004
Vellore
TAMIL NADU
632004
India |
| Phone |
9942477410 |
| Fax |
|
| Email |
drkaverivallii@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr .Reginald George Alex. T |
| Designation |
Professor |
| Affiliation |
Dr. M. G. R. Medical University |
| Address |
Department of Emergency Medicine, Christian Medical College Vellore - 632004
Department of Emergency Medicine, Emergency building, room no.1 and D001. Christian Medical College Vellore - 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
8838119830 |
| Fax |
|
| Email |
dralex98@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR R Kaveri |
| Designation |
PG Register |
| Affiliation |
Christian medical college Vellore-632004 |
| Address |
Christian Medical College Vellore - 632004
Department of emergency medicine, Emergency building, room No.1 and D001.
CMC Vellore-632004
Vellore
TAMIL NADU
632004
India |
| Phone |
9942477410 |
| Fax |
|
| Email |
drkaverivallii@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine
Christian medical College. Vellore-632004
India. |
|
|
Primary Sponsor
|
| Name |
Christian medical college Vellore |
| Address |
Internal-Fluid research grant ( Rs. 1,50,000-Per Year for 2 years) |
| 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 R Kaveri |
Christian Medical College and Hospital. Vellore - 632004 |
Department of Emergency Medicine, Emergency building, Room No.1 and D001. Christian medical College. Vellore-632004.
Vellore
TAMIL NADU |
09942477410
drkaverivallii@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CDSCO |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Ketorolac tromethamine
1 amp is 1 ml as 30 mg |
Intervention arm : Inj. Ketorolac tromethamine 30 mg in 100 ml Normal saline over 20 min, once administration. Total duration 150 min.
|
| Comparator Agent |
Inj. Tramadol
1 ampoule is 2 ml as 100 mg
|
Comparator arm : Inj. Tramadol 100 mg in 100 ml Normal saline over 20 min, once administration. Total duration 150 min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients(Patients more than 18 years of age)
2.Patients with suspected acute renal colic presenting to the ED(typical colicky flank pain and with or without hematuria) with plan for imaging per standard care.
3.patients with moderate to severe pain at baseline(e.g.NRS more than or equal to 4/10
4.Patients willing to provide informed written consent to participate in the study.
4. |
|
| ExclusionCriteria |
| Details |
Patients with known allergy or hypersensitivity to NSAIDs, opioids or study drugs
Patients with history of peptic ulcer disease, gastrointestinal bleeding or known coagulopathy, platelet count 1 lakh per liter therapeutic anticoagulation where NSAIDs are contraindicated.
Severe renal impairment (eGFR Less than 30ml per min per 1.73 meter square) or known CKD stage 4-5.
pregnant or lactating women.
Hemodynamic instability ( SBP less than 90 mm HG)
or altered mental status precluding consent or assessment.
An alternative non renal colic diagnosis judged more likely on ED assessment (AAA, Appendicitis, ectopic pregnancy ) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the pain score at 30 and 60 minutes post administration of intravenous Ketorolac and Tramadol to patients with acute renal colic presenting to the Emergency department |
30min 60min 90min 120min and 150min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. To determine the adverse effects of intravenous Ketorolac and Tramadol in patients with acute renal colic presenting to the Emergency department
b. To determine the need for rescue analgesia between groups.
c. To determine patient satisfaction yes/no.
|
30mim 60min 90min 120min and 150min |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
25/04/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drkaverivallii@gmail.com].
- For how long will this data be available start date provided 22-04-2026 and end date provided 24-04-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized, single blinded, phase IV
superiority trial will compare the analgesic efficacy and safety of intravenous
Ketorolac tromethamine versus intravenous tramadol for acute renal colic in the
emergency department (ED). Adults greater than or equal to 18 years with suspected renal colic and
baseline moderate-to-severe pain (Numeric Rating Scale [NRS] greater than or equal to (4) will be
enrolled after informed consent. Participants will be randomized 1:1 by
computer-generated sequence with allocation concealed using sequentially
numbered, opaque, sealed envelopes. The study will enroll 100
participants (50 per arm), providing 90 percent power (alpha=0.05) to detect the
prespecified difference in pain-score change. Analyses
will follow intention-to-treat the primary endpoint will be compared using
chi-square or Fisher’s exact with risk ratio, risk difference, and 95 percent CIs, with
adjusted models as sensitivity analyses. The trial will obtain IRB approval and
registration before enrolment; post-trial, all participants will continue to
receive best available standard care. Tramadol
is the standard of care in Emergency department. There is minimal studies in comparing
IV Ketorolac and tramadol hence we want to carryout this study in Emergency
department. |