Semir Nouira
Monastir, Tunisia
Location status: Recruiting
NCT Number: NCT06345716
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.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Phase 2
Monastir, Tunisia
Location status: Recruiting
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days
Other names: B
Each patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days
Other names: A
Each patient received 1 tab * 3 / d of placebo (flour) every day for 7 days
Other names: C
Time frame: 7 day after inclusion
included recurrence of RC and ED readmission within 7-day follow-up
Time frame: 7 day after inclusion
mean time to recurrence of pain
Time frame: 7 days 30 days
occurence of side effects
Time frame: 7 days 30 days
-Adverse effects of treatment and its tolerance.
Contact information is provided by the study sponsor or research team.
University of Monastir
Other
Acronym: RC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05776953
Agnosia, Analgesia
Hackensack, New Jersey, United States
View Trial DetailsNCT06978816
Acupuncture, Ear, Calculi
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT07070401
Agnosia, Calculi
Toms River, New Jersey, United States
View Trial DetailsNCT05722782
Neurologic Manifestations, Pain
Monastir, Tunisia
View Trial Details