Pain treatment in renal colics; the role of Instanyl ® in prevention of hospitalizatio

Conditions: Renal colic
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-001370-28-NL

Lead Sponsor: Afdeling Urologie, Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

- Contra-indications for NSAID's or intranasal opioids (Instanyl)
- Opioid tolerant patients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>;Timepoint(s) of evaluation of this end point: T1 = 20 minutes after first administration of Instanyl ®

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 2. Adverse events<br>3. Duration of pain reduction before need for Butylscopolamin IV,;Timepoint(s) of evaluation of this end point: 1. T1 (20 min)<br>2. When mentioned by the patient.<br>3. When (in minutes) the decision is made to administer butylscopolamine.<br>4. 2 weeks after inclusion.