DeliriumPhase 3NCT00819988
Pregabalin in the Prevention of Postoperative Delirium and Pain
A Phase 3 study testing Pregabalin and Sugar pill in people with Delirium and Pain, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Pregabalin and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 60 years and older
- booked for major orthopaedic or vascular procedure
- expected length of stay > 2 days
Who cannot join
- 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
Show all 9Show fewer
- seizure disorder
- MMSE < 24/30
- inability to speak English or French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety and Efficacy of the Perioperative Administration of Pregabalin in Reducing the Incidence of Postoperative Delirium and Improving Acute Postoperative Pain Management
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.
Read the detailed 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.
- Being tested
- Pregabalin, Sugar pill
- Keywords
- Postoperative, Perioperative, Orthopedic surgery, Vascular surgery, Gabapentinoid
- Medical subject headings
- Delirium, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
Pregabalin capsule 75 mg given preoperatively, then eith 50 mg or 25 mg given every 8 hours for 3 days postoperatively based on renal function
Sugar pillOther
Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively Receives: Other: Sugar pill |
| Pregabalin | Experimental | 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 Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)
Measured: postoperative day 1, 2, 3
Secondary outcomes (9)
Interference with daily activities using BPI
Measured: postoperative day 3
Pain at rest using NRS
Measured: postoperative days 1, 2, 3
Pain with movement of the operative site using NRS
Measured: postoperative days 1, 2, 3
Narcotic analgesic requirements
Measured: postoperative days 0, 1, 2, 3
Sedation using RSS
Measured: postoperative days 1, 2, 3
Narcotic-related adverse effects using ORSDS
Measured: postoperative days 1, 2, 3
Recovery using the QoR
Measured: postoperative day 3
Length of stay
Measured: Discharge day
Medical Outcome Study (MOS) sleep score
Measured: Postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Dr. A. Chaput, Ottawa Hospital Research Institute
- Investigators
- Alan J Chaput, MD, MSc, Principal investigator, The Ottawa HospitalHomer Yang, MD, Study director, The Ottawa HospitalGregory L Bryson, MD, MSc, Study director, The Ottawa HospitalHolly Evans, MD, Study director, The Ottawa HospitalPaul Beaule, MD, Study director, The Ottawa HospitalPrasad Jetty, MD, Study director, The Ottawa HospitalBarbara Power, MD, Study director, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819988
- Sponsor's protocol ID
- PSI2008525
- Status last verified
- Jan 2012
- First submitted
- 8 Jan 2009
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
PubMed 2240918Bitsch M, Foss N, Kristensen B, Kehlet H. Pathogenesis of and management strategies for postoperative delirium after hip fracture: a review. Acta Orthop Scand. 2004 Aug;75(4):378-89. doi: 10.1080/00016470410001123.
PubMed 15370579Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. doi: 10.1093/gerona/58.1.m76.
PubMed 12560416Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3.
PubMed 12817919Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. doi: 10.1097/00000539-199804000-00019.
PubMed 9539601Gilron I. Review article: the role of anticonvulsant drugs in postoperative pain management: a bench-to-bedside perspective. Can J Anaesth. 2006 Jun;53(6):562-71. doi: 10.1007/BF03021846.
PubMed 16738290Peng PW, Wijeysundera DN, Li CC. Use of gabapentin for perioperative pain control -- a meta-analysis. Pain Res Manag. 2007 Summer;12(2):85-92. doi: 10.1155/2007/840572.
PubMed 17505569Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. doi: 10.1212/01.wnl.0000233831.87781.a9. Epub 2006 Aug 16.
PubMed 16914695
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety and Efficacy of the Perioperative Administration of Pregabalin in Reducing the Incidence of Postoperative Delirium and Improving Acute Postoperative Pain Management
- ClinicalTrials.gov ID
- NCT00819988
- Acronym / sponsor ID
- PSI2008525
- Keywords
- Postoperative, Perioperative, Orthopedic surgery, Vascular surgery, Gabapentinoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Other: Sugar pillSingle dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively |
| Pregabalin | Experimental | Drug: PregabalinSingle 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 60 years and older
- booked for major orthopaedic or vascular procedure
- expected length of stay > 2 days
Key exclusion criteria (9 listed)
- open AAA repair
- EVAR
- allergy/sensitivity to pregabalin or gabapentin
- use of pregabalin or gabapentin in previous 14 days
- severe liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: LyricaPregabalin capsule 75 mg given preoperatively, then eith 50 mg or 25 mg given every 8 hours for 3 days postoperatively based on renal function | Drug | Pregabalin |
| Sugar pillSingle dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively | Other | Sugar pill |
Primary outcome
Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)
Time frame: postoperative day 1, 2, 3
9 secondary outcomes
Interference with daily activities using BPI
Time frame: postoperative day 3
Pain at rest using NRS
Time frame: postoperative days 1, 2, 3
Pain with movement of the operative site using NRS
Time frame: postoperative days 1, 2, 3
Narcotic analgesic requirements
Time frame: postoperative days 0, 1, 2, 3
Sedation using RSS
Time frame: postoperative days 1, 2, 3
Narcotic-related adverse effects using ORSDS
Time frame: postoperative days 1, 2, 3
Recovery using the QoR
Time frame: postoperative day 3
Length of stay
Time frame: Discharge day
Medical Outcome Study (MOS) sleep score
Time frame: Postoperative day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2012.
- Background: PubMed 2240918Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
- Background: PubMed 15370579Bitsch M, Foss N, Kristensen B, Kehlet H. Pathogenesis of and management strategies for postoperative delirium after hip fracture: a review. Acta Orthop Scand. 2004 Aug;75(4):378-89. doi: 10.1080/00016470410001123.
- Background: PubMed 12560416Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. doi: 10.1093/gerona/58.1.m76.
- Background: PubMed 12817919Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3.
- Background: PubMed 9539601Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. doi: 10.1097/00000539-199804000-00019.
- Background: PubMed 16738290Gilron I. Review article: the role of anticonvulsant drugs in postoperative pain management: a bench-to-bedside perspective. Can J Anaesth. 2006 Jun;53(6):562-71. doi: 10.1007/BF03021846.
- Background: PubMed 17505569Peng PW, Wijeysundera DN, Li CC. Use of gabapentin for perioperative pain control -- a meta-analysis. Pain Res Manag. 2007 Summer;12(2):85-92. doi: 10.1155/2007/840572.
- Background: PubMed 16914695Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. doi: 10.1212/01.wnl.0000233831.87781.a9. Epub 2006 Aug 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan J Chaput, MD, MSc principal investigator
The Ottawa Hospital
Homer Yang, MD study director
The Ottawa Hospital
Gregory L Bryson, MD, MSc study director
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin and Sugar pill in people with Delirium and Pain, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (patient is either CAM-ICU positive or positive for delirium by chart review) (time frame: postoperative day 1, 2, 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819988, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2012.