Renal Colic, Pain
Conditions
Keywords
Renal colic, Pain, Desmopressin, Urinary obstruction, Indomethacin
Brief summary
In this study we will compare pain intensity and side effects at different time points after the intranasal administration of desmopressin or placebo in patients with acute renal colic pain.
Detailed description
Obstruction of the urinary tract can increase pelvi-ureteric pressure and thus cause renal colic pain, which can be very severe. Conventional therapy consists of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. NSAIDs have many side effects and opioids are not always available. In addition, the intravenous form of NSAIDs is not routinely available in Iran, and the drug is mainly used in the form of suppository. Due to these reasons, research on newer replacement therapies with fewer side effects is necessary. Desmopressin intranasal spray has already been shown to be partially effective in renal colic pain in a few studies. Due to its lower side effects, we decided to conduct a clinical trial with desmopressin to evaluate pain relief in renal colic. In this study, eighty-eight patients with acute renal colic pain, referring to Imam Khomeini Hospital in Tehran, will be randomly allocated to receive either intranasal desmopressin or placebo. Both groups will also receive 100 milligram indomethacin suppository. Pain intensity will be assessed and recorded using a verbal numeric rating scale, before nasal spray, and in minutes 5, 10, 15, 30, 45 and 60 after receiving the allocated treatment. Possible side effects will also be asked and recorded. The patient and the investigator responsible for recording pain intensity will not be aware of the administered drug. The results will be compared before and after treatment in each group, using appropriate statistical tests.
Interventions
DRUGDesmopressin intranasal spray
10 microgram per puff, 40 microgram is Descript
Saline spray identical to desmopressin, administered as 4 sprays
Indomethacin suppository 100 milligram single dose
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 15 to 65 years * Pain intensity of at least 3 * Clinical diagnosis of renal colic
Exclusion criteria
* History of hypertension * History of acute myocardial ischemia * History of hyponatremia * Presence of acute rhinitis and flu * Coagulopathy or anticoagulant therapy * History of peptic ulcer disease, asthma, renal failure, severe liver failure * Analgesic use over 4 hours ago * Taking seizure medications (such as carbamazepine) * Taking any of the following drugs: chlorpropamide, warfarin, clofibrate , epinephrine, Fludrocortisone, heparin, lithium, alcohol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | baseline till one hour | Changes in pain intensity using a verbal numeric rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | One hour | Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of opioid as a rescue drug | One hour | Whether or not the patient care team had to administer opioids due to uncontrolled pain |
Countries
Iran
Contacts
Primary ContactMohammad Jalili, MD
Outcome results
None listed