Main objective: To evaluate the pain reduction in patients receiving Instanyl®Secondary objectives: To evaluate; the duration of pain reduction in patients receiving Instanyl®; the degree of adverse effects in patients receiving Instanyl®: whether…
ID
Source
Brief title
Condition
- Urolithiases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the main parameter is the pain reduction after 20 minutes measured on a 100 mm
VAS-score.
Secondary outcome
- The need for butylscopolamin after 20 minutes
- Adverse reactions are expressed as being present (=1) or being absent (=0)
- The time elapsed until butylscopolamin is administered.
- 2 weeks after participation it will be noted whether (=1) or not (=0) the
participant presented a second time with renal colics and was treated with
butylscopolamine.
Background summary
Renal colics are an acute and severe pain occurring when a renal stone
obstructs the urinary flow in through the ureter. Standard treatment constists
of NSAID*s. When the pain relief is insufficient, patients are administered
butylscopolamine intravenousely. This procedure is costly and inconvenient for
the patient. Instanyl® is an opioid analgesic indicated for use in patients
with breakthrough cancer pain. It could reduce pain in acute renal colics and
reduce the need for butylscopolamine as it is fast and efficient.
Study objective
Main objective: To evaluate the pain reduction in patients receiving Instanyl®
Secondary objectives: To evaluate; the duration of pain reduction in patients
receiving Instanyl®; the degree of adverse effects in patients receiving
Instanyl®: whether use of Instanyl® on-demand reduces the need for intravenous
butylscopolamine in patients presenting with an acute renal colic.
Study design
Clinical outcomes study.
Intervention
Participants receive a nasal spray containing 59 microgram/dose Instanyl®. They
are administered a single dose.
Study burden and risks
Potential benefits are the additional analgetics and potentially no need for
butylscopolamine. The assosiated risks are the adverse events of Instanyl®. As
with other opiods, the most serious risk is respiratory depression. The extend
of the burden consists of; administration to the hospital; VAS-scores and
measurements of blood pressure, pulse and oxygen every hour.
Groot Weezenland 20
Zwolle 8000 GM
NL
Groot Weezenland 20
Zwolle 8000 GM
NL
Listed location countries
Age
Inclusion criteria
Age: 18 years or older;Renal colic;Opioid naive;Informed consent obtained
Exclusion criteria
- Contra-indications for NSAID's or intranasal opioids;- Opioid tolerant patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-001370-28-NL |
| CCMO | NL40180.075.12 |