Back to resultsAnalgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
Primary Purpose
Rib Fractures, Pain
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Intranasal calcitonin
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fractures focused on measuring Rib fracture, Pain, intranasal calcitonin
Eligibility 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.
Sites / Locations
- Hôpital du Sacré-Coeur
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00444808
Brief Title
Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
Official Title
Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
Medication expired
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Université de Montréal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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®).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures, Pain
Keywords
Rib fracture, Pain, intranasal calcitonin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Intranasal calcitonin
Primary Outcome Measure Information:
Title
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.
Title
and/or reduction the use of back-up medication on days 1, 3, 7, 14, 21, 28.
Secondary Outcome Measure Information:
Title
Improvement in the quality of life and sleep.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raoul Daoust, MD
Organizational Affiliation
Centre de recherche hôpital du Sacré-Coeur de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital du Sacré-Coeur
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
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