Renal Colic
Conditions
Keywords
Renal colic, Piroxicam
Brief summary
Outpatients treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this matter. The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency departement after the first line treatment of a renal colic investigating the recurrence of pain, the reconsultation rates and the admissions.
Detailed description
Renal colic (RC)are a frequent cause of consultation in the emergency departement (ED). They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain. The first line treatment of renal colics is based on NSAI drugs associated with antalgics and is further investigated in the NSAI vs Morphine study (NCT02156596). But there is no clear recommendations regarding the outpatient treatment of renal colics. Oral NSAI are still widely used as a second line medicine for this condition and variety of molecules were tried with no solid scientific arguments. Piroxicam, a non-selective COX inhibitor drug appared to the Oxicam class of NSAI, is widely used to treat rheumatoid conditions and other inflammatory conditions and often prescribed in Tunisia as a second line treatment of RC. In this study, we aimed to investigate the efficiency and safety of the use of oral NSAI drugs (Piroxicam) compared to paracetamol or placebo as a second line treatment of renal colics.
Interventions
DRUGPiroxicam
Patients allocated to this arm received, as a second line treatment of renal colics, a five days treatment with 20 mg piroxicam associated with placebo per day and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.
DRUGPlacebo
Patients allocated to this arm received a five days treatment with Placebo and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.
DRUGparacetamol
Patients allocated to this arm received a five days treatment with Paracetamol and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years old * Consenting to participate in the study * Patients treated in the ED for RC * No contraindications of NSAI treatment
Exclusion criteria
* Patients excluded from the first phase of the study * Contraindication of NSAI treatment * Patients non reachable by telephone call * Patients that did not receive or use the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments) | seven days | The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the recurrence of painand the readmission rates) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of NSAI (telephone call, asking for mean time to recurrence and the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect) | seven days | The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect |
Countries
Tunisia
Outcome results
None listed