Effect of ketorolac and dexamethasone injections on pain after renal stent surgery
| ISRCTN | ISRCTN14221501 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14221501 |
| Secondary identifying numbers | CFBCR.REC.2023019 |
- Submission date
- 04/03/2024
- Registration date
- 06/03/2024
- Last edited
- 06/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Many patients suffer from kidney stone surgery particularly the insertion of a ureteral stent (a thin tube inserted into the ureter). After stent removal, a high percentage of patients experience substantial kidney pain. The aim of this study is to investigate whether the administration of ketorolac and dexamethasone during stent removal can decrease the level of kidney pain.
Who can participate?:
Adult patients aged 18 to 85 years who undergo stent placement for kidney/ureteral stones
What does the study involve?:
Patients will be randomly placed into three study groups: the ketorolac group, which will receive an intramuscular injection (into a muscle) of ketorolac and an intramuscular injection of 0.9% normal saline within 30 minutes of stent removal, the ketorolac and dexamethasone group, which will receive an intramuscular injection of ketorolac and dexamethasone within 30 minutes of stent removal, and the placebo group, which will receive two intramuscular injections of 0.9% normal saline. All patients will be assessed 1 and 7 days after stent removal.
What are the possible benefits and risks of participating?
The possible benefits are decreased level of kidney pain and fewer missed days of work after stent removal. The possible risks are injection site reactions and infections.
Where is the study run from?
Erfain Hospital (Iran)
When is the study starting and how long is it expected to run for?
December 2023 to April 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mohammadreza Noroozi, noroozi.mr@cfbcr.org
Contact information
Public, Scientific, Principal Investigator
Shahid Riazi Bakhshayesh St. Saadat Abad
Tehran
1945784320
Iran
| Phone | +98 (0)9122328891 |
|---|---|
| noroozi.mr@cfbcr.org |
Study information
| Study design | Randomized triple-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Efficacy and safety of intramuscular ketorolac and dexamethasone for preventing renal colic post stent removal: a randomized triple-blind, placebo-controlled clinical trial |
| Study hypothesis | Intramuscular ketorolac and dexamethasone alleviate renal pain after stent removal |
| Ethics approval(s) |
Approved 05/12/2023, Ethics Committee of Center for Fundamental, Biomedical and Clinical Research (Shahid Riazi Bakhshayesh St. Saadat Abad, Tehran, 1945784320, Iran; +98 (0)2161323389; vcr@cfbcr.org), ref: CFBCR.REC.2023019 |
| Condition | Preventing renal colic post stent removal |
| Intervention | 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 tromethamine, 30 mg in 1 ml) and an intramuscular injection of 1 ml of 0.9% normal saline within 30 minutes of stent removal 2. Ketorolac and dexamethasone group (KD group), which will receive an intramuscular injection of ketorolac (Ketorolac tromethamine, 30 mg in 1 ml) and dexamethasone (dexamethasone phosphate, 8 mg in 2 ml) within 30 minutes of stent removal 3. Placebo group (P group), which will receive two intramuscular injections of 1 ml of 0.9% normal saline. A blinded, qualified nurse performed the injections. All patients will be assessed 1 and 7 days after stent removal. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Ketorolac tromethamine, dexamethasone phosphate |
| Primary outcome measure | Pain measured using the visual analogue score (VAS) on day 1 and day 7 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2023 |
| Overall study end date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 174 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 15/03/2024 |
| Recruitment end date | 29/04/2024 |
Locations
Countries of recruitment
- Iran
Study participating centre
Tehran
1945784687
Iran
Sponsor information
Research organisation
Shahid Riazi Bakhshayesh St. Saadat Abad
Tehran
1945784320
Iran
| Phone | +98 (0)2161323389 |
|---|---|
| cfbcr@cfbcr.org |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
04/03/2024: Study's existence confirmed by the Ethics Committee of Center for Fundamental, Biomedical and Clinical Research.
