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

NCT06345716 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Renal Colic

Interventions

DRUG

paracétamol tramadol

Each patient received 1 tablet \* 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days

DRUG

Paracétamol cafeine

Each patient received 1 tab \* 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days

DRUG

Placebo

Each patient received 1 tab \* 3 / d of placebo (flour) every day for 7 days

Sponsors & Collaborators

  • University of Monastir

    lead OTHER

Principal Investigators

  • Khaoula Bel Haj Ali · CHU Fattouma Bourguiba Monastir, service des urgences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-10
Primary Completion
2025-03-15
Completion
2025-11-30

Countries

  • Tunisia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06345716 on ClinicalTrials.gov