Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics

ConditionRenal Colic

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Monastir

About this trial

Treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this subject.

The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency department after the first line treatment of a renal colic investigating the reccurence of pain, the reconsultation rates and the admissions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years old

Consenting to participate in the study

Patients treated in the ED for RC

No contraindications of NSAI or paracetamol treatment

Disqualifiers

Contraindication of NSAI treatment

Patients non reachable by telephone call

Patients that did not receive or use the treatment

Trial design

Design model

Parallel

Treatments tested in this trial

Piroxicam
Drug
Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with 20 mg piroxicam per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment
Acetaminophen
Drug
Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with 1000 mg Acetaminophen per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment
Placebo
Drug
Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with placebo per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment

Treatment groups

500 Participants

are divided into 3 treatment groups

Group A: NSAIActive comparator 1 intervention

Group B: AcetaminophenActive comparator 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Efficacity of oral NSAI

The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the reccurence of pain, the reconsultation rates and intervals and the need for other treatments (antalgics...)

Time frame

07 days

Secondary outcomes

Safety of NSAI

Safety was evaluated by a telephone call asking for the occurence of NSAI side effects such as abdominal pain , vomiting , rush, bleeding or others

Time frame

07 days

Sponsors and contacts

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University of Monastir

Lead sponsor

Source ClinicalTrials.gov

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