Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 analgesia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

1. Patient consent.

2. Age 18 years to 60 years.

3. Isolated limb bone fracture/s.

Exclusion Criteria:

1. Patient refusal.

2. Age 61 years and older.

3. Known allergy to study medication.

4. Multiple bone fractures in different limbs.

5. Multiple trauma.

6. Oncological patients.

7. Respiratory depression / respiratory insufficiency / hypercarbia.

8. Acute bronchial asthma.

9. CNS depression / hallucinations.

10. Alzheimer / dementia.

11. Known convulsive disorder.

12. Prostate hypertrophy.

13. Paralytic ileus.

14. Renal dysfunction (plasma creatinine > 1.5).

15. Liver dysfunction.

16. Adrenocortical insufficiency.

17. Hypothyroidism.

18. Pancreatitis.

19. Pregnancy and lactating.

20. Drug abuse, current or in the past.

21. Alcohol abuse on admission to operating room.