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Effect of ketorolac and dexamethasone injections on pain after renal stent surgery

Efficacy and safety of intramuscular ketorolac and dexamethasone for preventing renal colic post stent removal: a randomized triple-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14221501
Enrollment
174
Registered
2024-03-06
Start date
2024-03-15
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Preventing renal colic post stent removal Urological and Genital Diseases

Interventions

Patients will be randomized into three study groups (block randomization with a block size of 6): 1. Ketorolac group (K group), which will receive an intramuscular injection of ketorolac (ketorolac tr

Sponsors

Center for Fundamental Biomedical Clinical Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients who underwent stent placement for renal/ureteral stones and returned for cystoscopical stent removal 2. Age between 20 and 85 years old 3. Providing informed consent

Exclusion criteria

Exclusion criteria: 1. Absolute or relative contraindication to ketorolac or dexamethasone 2. Acute or chronic renal failure (estimated glomerular filtration rate <50) 3. History of GI bleeding or peptic ulcer disease 4. Elevated risk of bleeding including cerebrovascular bleeding, haemorrhagic diathesis, use of any anticoagulants, or any bleeding disorder 5. Systemic infections or cerebral malaria 6. Use of live or live-attenuated vaccines 6. Concurrent use of NSAIDs or corticosteroids 7. Pregnancy 8. Breastfeeding

Design outcomes

Primary

MeasureTime frame
Pain measured using the visual analogue score (VAS) on day 1 and day 7

Secondary

MeasureTime frame
1. Opioid use, measured by the number of patients with any opioid use on day 1 2. Urgent pain-related clinical encounters, measured by the number of pain-related clinical encounters in the emergency department since the stent removal 3. Subjective renal colic symptoms, measured by the number of patients that experienced renal colic symptoms since the stent removal to day 7 4. Missed days of work, measured by the number of missed days of work since the stent removal to day 7 5. Injection complications, measured as the number of patients with any injection complication since the stent removal to day 7

Countries

Iran

Contacts

Public ContactMohammadreza Noroozi
noroozi.mr@cfbcr.org+98 (0)9122328891

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026