Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
Information source: University of Montreal
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rib Fractures; Pain
Intervention: Intranasal calcitonin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University of Montreal Official(s) and/or principal investigator(s):
Raoul Daoust, MD, Principal Investigator, Affiliation: Centre de recherche hôpital du Sacré-Coeur de Montréal
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®).
Clinical Details
Official title: Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: Improvement in the quality of life and sleep.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Hôpital du Sacré-Coeur, Montréal, Quebec H4J 1C5, Canada
Additional Information
Starting date: February 2007
Ending date: January 2008
Last updated: June 2, 2008
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