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

NCT06345716 | Recruiting Phase 2

• 1 other identifier: renal colic 2024
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

renal colic; paracetamol-tramadol; paracetamol-cafeine; placebo

Outcome Measures

Primary Outcomes (1)

• Recurrence of RC and ED readmission

  included recurrence of RC and ED readmission within 7-day follow-up

  7 day after inclusion

Secondary Outcomes (2)

• mean time interval

  7 day after inclusion

• side effects

  7 days 30 days

Other Outcomes (1)

• Adverse effects

  7 days 30 days

Study Arms (3)

Paracétamol-tramadol

EXPERIMENTAL

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

Drug: paracétamol tramadol

Paracetamol-caffeine

EXPERIMENTAL

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

Drug: Paracétamol cafeine

Placebo

EXPERIMENTAL

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

Interventions

paracétamol tramadol DRUG

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

Also known as: B

Paracétamol-tramadol

Paracétamol cafeine DRUG

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

Also known as: A

Paracetamol-caffeine

Placebo DRUG

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

Also known as: C

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Inability to appreciate pain according to the VAS.
• Pregnant or breastfeeding woman.
• Renal insufficiency with creatinine clearance \< 60 ml/min.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Semir Nouira

Monastir, Tunisia

RECRUITING

MeSH Terms

Conditions

Renal Colic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Khaoula Bel Haj Ali

  CHU Fattouma Bourguiba Monastir, service des urgences

  STUDY DIRECTOR

Central Study Contacts

Khaoula Bel Haj Ali

CONTACT

99792724; belhajalikhaoula@yahoo.fr

Semir Nouira, Pr

CONTACT

21673106046

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 3, 2024
• Study Start: April 10, 2024
• Primary Completion: March 15, 2025
• Study Completion: November 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)