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Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

This study has been terminated.
(Medication expired)
Information provided by:
Université de Montréal Identifier:
First received: March 7, 2007
Last updated: June 2, 2008
Last verified: June 2008

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
Drug: Intranasal calcitonin
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Université de Montréal:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00444808

Canada, Quebec
Hôpital du Sacré-Coeur
Montréal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Université de Montréal
Principal Investigator: Raoul Daoust, MD Centre de recherche hôpital du Sacré-Coeur de Montréal
  More Information

Responsible Party: Raoul Daoust, University of Montreal 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

Keywords provided by Université de Montréal:
Rib fracture
intranasal calcitonin

Additional relevant MeSH terms:
Rib Fractures
Fractures, Bone
Wounds and Injuries
Thoracic Injuries
Salmon calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Vasodilator Agents
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 28, 2017