Renal colic
Conditions
Interventions
Trade Name: Instanyl 50 micrograms nasal spray, solution
Product Name: Instanyl 50 micrograms nasal spray, solution
Pharmaceutical Form: Nasal spray
Sponsors
Afdeling Urologie, Isala Klinieken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: 18 years or older Renal colic Opioid naive (previeuous 7 days or less of daily opioid usage) Informed consent obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Contra-indications for NSAID's or intranasal opioids (Instanyl) - Opioid tolerant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether use of Instanyl® on-demand reduces the pain in patients presenting with an acute renal colic;Secondary Objective: To evaluate; the duration of pain reduction in patients receiving Instanyl®; the degree of adverse effects in patients receiving Instanyl®.;Primary end point(s): 1. The reduction of pain in mm on a 100 mm VAS-score after 20 minutes ;Timepoint(s) of evaluation of this end point: T1 = 20 minutes after first administration of Instanyl ® | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Adverse events 3. Duration of pain reduction before need for Butylscopolamin IV,;Timepoint(s) of evaluation of this end point: 1. T1 (20 min) 2. When mentioned by the patient. 3. When (in minutes) the decision is made to administer butylscopolamine. 4. 2 weeks after inclusion. | — |
Countries
Netherlands
Contacts
Public ContactStichting Onderzoek Urologie Zwolle
Afdeling Urologie, Isala Klinieken
Outcome results
None listed