Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic

Renal Colic Clinical Trial

— RC  

Official title:

Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345716
• Other study ID #: renal colic 2024
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Colic
• Emergencies
• Renal Colic

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