Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 we 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®).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rib Fractures Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Rib fracture Pain intranasal calcitonin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intranasal calcitonin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 says yes to the question "do you wish something for your pain" (the result of the quantitative assessment of the pain in not taken into consideration) or the patient has already received an analgesic before the initial assessment by the emergency physician.
* The patient is seen no more than 48 hours after the accident.

Exclusion Criteria

* The patient is already receiving SC.
* Allergy or intolerance to SC, oxycodone chlorhydrate or acetaminophen
* Active neoplasia history for at least 5 years
* Toxicomania history as revealed by case history
* Osteoporosis linked to hyperparathyroidism
* Patient already using opiate analgesics or other analgesics on a regular basis (excluding aspirin at doses of 325 mg or less, as a prophylactic for cardiovascular diseases and under stable posology for at least 15 days)
* Steroid use within the past month
* Pregnancy, breast feeding
* Non-availability of patient for telephone follow-ups or follow-up appointments.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Montreal

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raoul Daoust, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche hôpital du Sacré-Coeur de Montréal

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital du Sacré-Coeur

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C.E. 2004-11-77

Identifier Type: -

Identifier Source: org_study_id