Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

What Was Tested

This registered phase 4 trial tested Calcitonin.

This study, which will be conducted at the emergency room of the Sacré-Cœur hospital, requires the recruitment of 60 subjects and involves some telephone follow-up.

Calcitonin administered as an intranasal spray is already used to relieve pain caused by broken vertebrae and the researchers seek to determine if it can be as efficient in the case of pain caused by broken ribs.This study aims at testing the hypothesis that subjects suffering from the accidental fracture of one or more ribs will get relief through the intranasal spraying of calcitonin and/or will use less opiate medication for pain relief (a combination of oxycodone chlorhydrate and acetaminophen called Percocet®).

The registry classes the interventions as drug.

Who Took Part

19 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients aged 18 or more. Accidental rib fracture (one or more) visible on a lung\\thorax radiography, or on a CT Scan of the thorax, as determined by the emergency physician or the radiologist. The rib fracture is the main cause of pain. The patient is seen no more than 48 hours after the accident.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: the patient is already receiving sc; allergy or intolerance to sc, oxycodone chlorhydrate or acetaminophen; active neoplasia history for at least 5 years.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

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

As a double-blind Calcitonin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2007-02 with completion listed for 2008-01.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Calcitonin in 19 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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