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

ConditionRenal Colic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Monastir

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

-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).

Disqualifiers

-Inability to appreciate pain according to the VAS.

Pregnant or breastfeeding woman.

Renal insufficiency with creatinine clearance < 60 ml/min.

Trial design

Design model

Parallel

Treatments tested in this trial

  • paracétamol tramadol

    Drug

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

  • Paracétamol cafeine

    Drug

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

  • Placebo

    Drug

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

Treatment groups

1,500 Participants
are divided into 3 treatment groups
Group A: Paracétamol-tramadolExperimental treatment 1 intervention
Group B: Paracetamol-caffeineExperimental treatment 1 intervention
Group C: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence of RC and ED readmission

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

Time frame
7 day after inclusion

Secondary outcomes

1

mean time interval

mean time to recurrence of pain

Time frame
7 day after inclusion
2

side effects

occurence of side effects

Time frame
7 days 30 days

Other outcomes

1

Adverse effects

-Adverse effects of treatment and its tolerance.

Time frame
7 days 30 days

Sponsors and contacts

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