Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

This study has been terminated.
(Medication expired)
Sponsor:
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT00444808
First received: March 7, 2007
Last updated: June 2, 2008
Last verified: June 2008

March 7, 2007
June 2, 2008
February 2007
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00444808 on ClinicalTrials.gov Archive Site
Improvement in the quality of life and sleep.
Same as current
Not Provided
Not Provided
 
Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

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®).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Rib Fractures
  • Pain
Drug: Intranasal calcitonin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
January 2008
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00444808
C.E. 2004-11-77
No
Raoul Daoust, University of Montreal
Université de Montréal
Not Provided
Principal Investigator: Raoul Daoust, MD Centre de recherche hôpital du Sacré-Coeur de Montréal
Université de Montréal
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP