Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

NCT00444808 | Terminated Phase 4

• 1 other identifier: C.E. 2004-11-77
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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®).

Conditions

Rib Fractures; Pain

Keywords

Rib fracture; Pain; intranasal calcitonin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Improvement in the quality of life and sleep.

Interventions

Intranasal calcitonin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

Hôpital du Sacré-Coeur

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Rib Fractures; Pain

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raoul Daoust, MD

  Centre de recherche hôpital du Sacré-Coeur de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: February 1, 2007
• Study Completion: January 1, 2008
• Last Updated: June 4, 2008

Record last verified: 2008-06

Locations

CA (1)