Renal Colic
Conditions
Keywords
Renal Colic, NSAI, Acetaminophen
Brief summary
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.
Detailed description
Renal colic (RC) are a frequent cause of consultation in the emergency departement (ED). It counts 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 non solid scientific arguments. Piroxicam, a non-selective COX inhibitor drug appared to the oxicam class of NSAI, is widely used to treat rhumatoid and inflammatory disesases, and often prescribed in Tunisia as a second line treatment of RC. In this study, the investigators aimed to investigate the efficiency and safety of the use of oral NSAI drugs (piroxicam) compared to Acetaminophen 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 per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment
DRUGAcetaminophen
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
DRUGPlacebo
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
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 or paracetamol treatment
Exclusion criteria
* 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 | 07 days | 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...) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of NSAI | 07 days | Safety was evaluated by a telephone call asking for the occurence of NSAI side effects such as abdominal pain , vomiting , rush, bleeding or others |
Countries
Tunisia
Contacts
Primary ContactNouira semir, MD
Outcome results
None listed