Pregabalin in the Prevention of Postoperative Delirium and Pain

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 3

Conditions: Delirium; Pain

Treatments: Drug: Pregabalin; Other: Sugar pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00819988

PSI2008525

Details and patient eligibility

About

The purpose of this study is to determine whether administration of pregabalin by mouth immediately preoperatively and three times daily for 3 days after surgery reduces the incidence of delirium postoperatively and improves overall pain control.

Full description

Delirium is a common postoperative complication occurring in up to 73% of patients sometime during their hospital stay. Elderly patients undergoing major surgical procedures are at highest risk. While many risk factors for delirium are known, the specific pathophysiology of postoperative delirium remains unclear and is likely multifactorial. The most common inciting agents and events include metabolic causes, medications, blood loss, hypoxemia and pain. Pain and its management are intimately related to the likelihood of developing postoperative delirium. As a class, gabapentinoids, such as pregabalin, have proven to reduce postoperative pain and narcotic consumption and therefore may have a role to play in the prevention of postoperative delirium.

Enrollment: 240 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 60 years and older
• booked for major orthopaedic or vascular procedure
• expected length of stay > 2 days

Exclusion criteria

• open AAA repair
• EVAR
• allergy/sensitivity to pregabalin or gabapentin
• use of pregabalin or gabapentin in previous 14 days
• severe liver disease
• severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent
• seizure disorder
• MMSE < 24/30
• inability to speak English or French

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Sugar pill

Placebo Comparator group

Description:

Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively

Treatment:

Other: Sugar pill

Pregabalin

Experimental group

Description:

Single dose of 75 mg given 30-60 minutes preoperatively, then 50 mg every 8 hours for 3 days postoperatively if creatinine clearance \> 60 ml/min OR 25 mg every 8 hours for 3 days postoperatively if creatinine clearance 30-60 ml/min

Treatment:

Drug: Pregabalin