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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06345716
Other study ID # renal colic 2024
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 10, 2024
Est. completion date November 30, 2025

Study information

Verified date April 2024
Source University of Monastir
Contact Khaoula Bel Haj Ali
Phone 99792724
Email belhajalikhaoula@yahoo.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.


Description:

This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group. Different parameters are collected on a standard form prepared for all cases of renal colic included in our study. This sheet essentially contains: Temperature, systolic and diastolic blood pressure, heart rate, pain intensity assessed by VAS, abdominal tenderness as well as the existence of Giardano signs. Additional examinations were not systematically carried out for all patients: AUSP, ECBU, renal ultrasound, creatinemia and blood sugar. Their realization depended on the clinical context. The use of imaging was done following the indications specified in the text of the consensus of the French Society of Emergency Medicine (updated in 2008)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1500
Est. completion date November 30, 2025
Est. primary completion date March 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - -Age > 18 years old. - Consent to participate in the study. - Pain in the flank/lumbar fossa of sudden onset with urine strips and/or imaging corresponding to the diagnosis of renal colic. - Pain score at discharge < 30 (visual analog scale - VAS or verbal numerical scale - VAS from 0 to 100). Exclusion Criteria: - -Inability to appreciate pain according to the VAS. - Pregnant or breastfeeding woman. - Renal insufficiency with creatinine clearance < 60 ml/min.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
paracétamol tramadol
Each patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days
Paracétamol cafeine
Each patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days
Placebo
Each patient received 1 tab * 3 / d of placebo (flour) every day for 7 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Monastir

Outcome

Type Measure Description Time frame Safety issue
Other Adverse effects -Adverse effects of treatment and its tolerance. 7 days 30 days
Primary Pain recurrence Pain recurrence is considered the only primary endpoint to compare the three study groups. 7 day after inclusion
Secondary Painful recurrence -The time for painful recurrence 7 day after inclusion
Secondary number of patient who revist the ED for residual pain number of patient who revist the ED for residual pain to obtain treatment for the acute crisis again 7 days 30 days
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