Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs - Full Text View

Sponsor:	University of Montreal
Information provided by:	University of Montreal
ClinicalTrials.gov Identifier:	NCT00444808

Purpose

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®).

Condition	Intervention	Phase
Rib Fractures Pain	Drug: Intranasal calcitonin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

Resource links provided by NLM:

MedlinePlus related topics: Fractures

Drug Information available for: Calcitonin human Calcitonin Fortical

U.S. FDA Resources

Further study details as provided by University of Montreal:

Primary Outcome Measures:

Reduction of the pain level by 30% as measured on the visual analog scale of 0-100 mm on days 1, 3, 7, 14, 21, 28.
and/or reduction the use of back-up medication on days 1, 3, 7, 14, 21, 28.

Secondary Outcome Measures:

Improvement in the quality of life and sleep.

Enrollment:	19
Study Start Date:	February 2007
Study Completion Date:	January 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444808

Locations

Canada, Quebec
Hôpital du Sacré-Coeur
Montréal, Quebec, Canada, H4J 1C5

Sponsors and Collaborators

University of Montreal

Investigators

Principal Investigator:

Raoul Daoust, MD

Centre de recherche hôpital du Sacré-Coeur de Montréal

More Information

No publications provided

Responsible Party:	Raoul Daoust, University of Montreal
ClinicalTrials.gov Identifier:	NCT00444808 History of Changes
Other Study ID Numbers:	C.E. 2004-11-77
Study First Received:	March 7, 2007
Last Updated:	June 2, 2008
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Montreal:

Rib fracture
Pain
intranasal calcitonin

Additional relevant MeSH terms:

Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries
Analgesics
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Bone Density Conservation Agents
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012