A study in comparing 2 pain relief medication in patients with kidney stone.

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. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108321

Enrollment

100

Registered

2026-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: N209- Urinary calculus, unspecified

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 )

Design outcomes

Primary

Measure	Time frame
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 departmentTimepoint: 30min 60min 90min 120min and 150min	—

Secondary

Measure	Time frame
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. Timepoint: 30mim 60min 90min 120min and 150min	—

Countries

India

Contacts

Public ContactDR R Kaveri

Dr. M. G. R. Medical University

dralex98@cmcvellore.ac.in8838119830

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026