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Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

This study has been terminated.
( Medication expired )

Sponsored by: 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

MedlinePlus related topics:   Fractures   

Drug Information available for:   Calcitonin    Calcitonin human    Fortical   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

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


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

Keywords provided by University of Montreal:
Rib fracture  
Pain  
intranasal calcitonin  

Study placed in the following topic categories:
Calcitonin Gene-Related Peptide
Calcitonin
Thoracic Injuries
Rib Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Pain
Salmon calcitonin

Additional relevant MeSH terms:
Vasodilator Agents
Therapeutic Uses
Physiological Effects of Drugs
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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