Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

What Was Tested

The trial (phase 3) is built around Desmopressin.

In this study the researchers 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.

It had two arms (groups): Desmopressin intranasal spray (experimental) and Placebo intranasal spray (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 88 planned participants were the target.

It was open to people of any sex aged from 15 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age: 15 to 65 years. Pain intensity of at least 3. Clinical diagnosis of renal colic.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: history of hypertension; history of acute myocardial ischemia; history of hyponatremia.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Desmopressin and who got the comparison, which limits bias.

The Desmopressin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Desmopressin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-03 with completion listed for 2013-03.

It ran at 2 sites in Iran (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Pain intensity (time frame: baseline till one hour).

It also tracked 1 secondary outcome, for example Side effects.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 88 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.