Trial | NCT00250237  Report issue

Title

Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Randomised Double-blind Placebo-controlled Study of Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    haloperidol ...

  • Study Participants

    220
In this study the investigators want to determine if treatment with haloperidol direct post-operatively after acute hip surgery in high risk patients protects against developing a post-operative delirium.
A post-operative delirium is a serious and frequent (35-65%) complication with high morbidity and mortality in high risk patients. In this study we investigate whether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75 years of age and older. It's a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.
Study Started
Nov 30
2005
Primary Completion
Nov 30
2008
Study Completion
Feb 28
2009
Last Update
Aug 07
2009
Estimate

Drug Haloperidol

Haloperidol 1mg twice daily during 72hours

Drug placebo

Placebo 1mg twice daily during 72hours

A Active Comparator

Patients receiving blinded medication (Haloperidol or Placebo)

B Placebo Comparator

Patients receiving blinded medication (Haloperidol or Placebo)

Criteria 

Inclusion Criteria:

Hip fracture
75 years and older

Exclusion Criteria:

Contra-indications for the use of haloperidol
Pre-operative delirium
Pre-operative use of haloperidol
No Results Posted