Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

Pain Clinical Trial

Official title:

Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00444808
• Other study ID #: C.E. 2004-11-77
• Status: Terminated
• Phase: Phase 4
• First received: March 7, 2007
• Last updated: June 2, 2008
• Start date: February 2007
• Est. completion date: January 2008

Study information

• Verified date: June 2008
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Rib Fractures

Intervention

Drug:
• Intranasal calcitonin

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Coeur	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	and/or reduction the use of back-up medication on days 1, 3, 7, 14, 21, 28.
Secondary	Improvement in the quality of life and sleep.