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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Colic
• Intervention / Treatment: Drug: paracétamol tramadol; Drug: Paracétamol cafeine; Drug: Placebo

Detailed 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)

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Khaoula Bel Haj Ali; Phone Number: 99792724; Email: belhajalikhaoula@yahoo.fr
• Study Contact Backup: Name: Semir Nouira, Pr; Phone Number: 21673106046

Study Locations

• Tunisia
  • Monastir, Tunisia
    • Recruiting
    • Semir Nouira
    • Contact: semir nouirq, professor; Phone Number: 0021673106046; Email: semir.nouira.urg@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paracétamol-tramadol; Each patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days.	Drug: paracétamol tramadol; Each patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days; Other Names: B
Experimental: Paracetamol-caffeine; Each patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days	Drug: Paracétamol cafeine; Each patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days; Other Names: A
Experimental: Placebo; Each patient received 1 tab * 3 / d of placebo (flour) every day for 7 days. *For the three groups, the tablets were packaged hermetically in identical envelopes taken at random to respect double blinding.	Drug: Placebo; Each patient received 1 tab * 3 / d of placebo (flour) every day for 7 days; Other Names: C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of RC and ED readmission	included recurrence of RC and ED readmission within 7-day follow-up	7 day after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean time interval	mean time to recurrence of pain	7 day after inclusion
side effects	occurence of side effects	7 days 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	-Adverse effects of treatment and its tolerance.	7 days 30 days

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Study Director: Khaoula Bel Haj Ali, CHU Fattouma Bourguiba Monastir, service des urgences

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: placebo; renal colic; paracetamol-tramadol; paracetamol-cafeine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Renal Colic; Colic; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Tramadol
• Other Study ID Numbers: renal colic 2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No