Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
This study has been terminated.
(Medication expired)
Sponsor:
Université de Montréal
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT00444808
First received: March 7, 2007
Last updated: June 2, 2008
Last verified: June 2008
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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 4 |
| 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:
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 |
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
Université de Montréal
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 Université de Montréal:
|
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 May 21, 2013