Status:
COMPLETED
Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Fractures
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
We would like to check whether pre-operative administration of an oral controlled-release opioid formulation (Oxycodone hydrochloride (OxyContin)) could result in a clear effect of preemptive analgesi...
Detailed Description
Preemptive analgesia is based on the concept of treating pain before inflicting the painful stimulus. One suggested mechanism is that transmission of pain signals is altered when the patient is treate...
Eligibility Criteria
Inclusion
- Patient consent.
- Age 18 years to 60 years.
- Isolated limb bone fracture/s.
Exclusion
- Patient refusal.
- Age 61 years and older.
- Known allergy to study medication.
- Multiple bone fractures in different limbs.
- Multiple trauma.
- Oncological patients.
- Respiratory depression / respiratory insufficiency / hypercarbia.
- Acute bronchial asthma.
- CNS depression / hallucinations.
- Alzheimer / dementia.
- Known convulsive disorder.
- Prostate hypertrophy.
- Paralytic ileus.
- Renal dysfunction (plasma creatinine \> 1.5).
- Liver dysfunction.
- Adrenocortical insufficiency.
- Hypothyroidism.
- Pancreatitis.
- Pregnancy and lactating.
- Drug abuse, current or in the past.
- Alcohol abuse on admission to operating room.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00254631
Start Date
April 1 2007
End Date
December 1 2008
Last Update
February 5 2015
Active Locations (1)
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1
RAMBAM Health Care Campus
Haifa, Israel, 31096