Comparison of two analgesic combinations for reno-ureteral colic treatment
| ISRCTN | ISRCTN13320231 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13320231 |
| Secondary identifying numbers | R-2021-3201-168 |
- Submission date
- 04/03/2022
- Registration date
- 04/04/2022
- Last edited
- 30/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Reno-ureteral colic happens when a stone gets lodged in your urinary tract, often in a ureter. The stone stretches and widens the area, causing intense pain.
The standard treatment consists of a painkiller (diclofenac) given directly via a vein, which is commonly combined with butylhyoscine. Such a combination lacks clinical evaluation in the literature, and a clinical practice guidelines suggest ketorolac and metamizole as second-line treatments. Given the complex behavior of reno-ureteral colic, the ketorolac and metamizole combination may represent a better clinical practice to benefit patients. The present study is aimed to evaluate the efficacy of ketorolac/metamizole versus diclofenac/butylhyoscine for reno-ureteral colic management.
Who can participate?
Patients with reno-ureteral colic and aged at least 18 years
What does the study involve?
Patients will be randomly allocated to a single dose of either ketorolac/metamizole or diclofenac/butylhyoscine, and will be monitored from baseline to 45 min.
What are the possible benefits and risks of participating?
The benefits include evidence-based management for reno-ureteral colic treatment, and the risks for such safe drugs might involve hypersensitivity to formulations.
Where is the study run from?
Instituto Mexicano del Seguro Social (Mexico)
When is the study starting and how long is it expected to run for?
September 2021 to September 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Julieta Godoy-Caballero, godoyjulieta957@gmail.com
Contact information
Principal Investigator
42 street, Serapio Rendon
Merida
97285
Mexico
 ORCID ID |
0000-0001-5150-5357 |
|---|---|
| Phone | +52 9999299831 |
| godoyjulieta957@gmail.com |
Study information
| Study design | Single center interventional blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 41300 PIS.pdf |
| Scientific title | Analgesic efficacy of ketorolac/metamizole versus diclofenac/butylhyoscine for reno- ureteral colic management in a primary-care hospital emergency service |
| Study acronym | KMDB |
| Study objectives | Ketorolac/metamizole analgesic efficacy is similiar to diclofenac/butylhyoscine in reno-ureteral colic management |
| Ethics approval(s) | Approved 26/11/2021, IMSS Local Health Research Committee 3201 (Comite Local de investigacion en salud del IMSS 3201, 41 street, Mérida Yucatán, México; no telephone number provided; comite.eticainv@imss.gob.mx), ref: R-2021-3201-168 |
| Health condition(s) or problem(s) studied | Reno-ureteral colic management |
| Intervention | Participants will be randomized 1:1 to receive the intervention or the comparison treatment. This process will occur when the patient arrives at the Emergency service from the primary-care hospital and will be performed with sealed envelopes containing the written informed consent, the pain-scale questionnaires, and a colored mark indicating the treatment that should be given. Patients in the intervention group will receive a single intramuscular dose of ketorolac (30mg) /metamizole (1g). Patients in the comparison group will receive diclofenac (75mg)/ butylhyoscina (20mg). Patients are then monitored for 45 minutes. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ketorolac, metamizole, diclofenac, butylhyoscine |
| Primary outcome measure | Pain is measured using a visual analogue scale (VAS) at baseline, 10, 20, and 45 min |
| Secondary outcome measures | The brief pain inventory (short form in Spanish) will be applied to assess the severity of pain and its impact on functioning at baseline |
| Overall study start date | 01/09/2021 |
| Completion date | 20/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 68 |
| Key inclusion criteria | 1. Aged 20 to 60 years 2. Clinical signs and symptoms of reno-ureteral colic |
| Key exclusion criteria | 1. Hypersensitivity to any of the tested drug formulations 2. Patients with severe reno- ureteral colic (with fever and chronic pain) 3. Grade III and IV renal insufficiency 4. Patients will be excluded if they have any pre-existing treatment that might interact with the tested drug 5. Patients will be excluded if they possess pre-existing digestive tube bleeding |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 30/04/2022 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Mérida
97285
Mexico
Sponsor information
Government
Instituto Mexicano del Seguro Social
42 Street, Serapio Rendon II
Merida Yucatan
Mexico City
CP. 97285
Mexico
| Phone | +52- 999-929-9831 |
|---|---|
| comite.eticainv@imss.gob.mx | |
| Website | http://www.imss.gob.mx/ |
"ROR" |
https://ror.org/03xddgg98 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The database will be available upon reasonable request. godoyjulieta957@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 10/03/2022 | No | Yes | ||
| Protocol file | 01/11/2021 | 10/03/2022 | No | No |
Additional files
Editorial Notes
30/08/2022: The overall end date was changed from 30/08/2022 to 20/09/2022.
14/07/2022: The overall trial end date has been changed from 30/07/2022 to 30/08/2022 and the plain English summary updated accordingly.
10/03/2022: Trial's existence confirmed by IMSS Local Health Research Committee 3201.
