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Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00444808
Enrollment
19
Registered
2007-03-08
Start date
2007-02-28
Completion date
2008-01-31
Last updated
2008-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Rib Fractures

Keywords

Rib fracture, Pain, intranasal calcitonin

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®).

Interventions

Sponsors

Université de Montréal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Improvement in the quality of life and sleep.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026