Self-Administered Versus Nurse Administered Pain Medication.NCT00221936
Patient Controlled Oral Analgesia for Postoperative Pain Management After Total Knee Replacement
A study testing Self-administration or nurse administered medication in people with Self-Administered Versus Nurse Administered Pain Medication., run by University Health Network, Toronto at 3 sites in Canada.
Trial summary
Patient Centered Care (PCC) is "an approach that consciously adopts the patient's perspective...about what matters" (Gerteis, Edgeman, Levitan, Walker, Stokes, Cleary, Delbanco, 1993). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Self-Administered Versus Nurse Administered Pain Medication.
- What is being tested?
- Self-administration or nurse administered medication
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2004to Jul 2005
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to read and write English
- post elective total knee replacement surgery (primary or revision)
- already on IV PCA
- age 18-80
- able to tolerate oral medication
- able to physically open a childproof vial independently (including the absence of any significant problems with manual power, dexterity or visual acuity)
- able and willing to complete Oral PCA flowsheet
Who cannot join
- history of substance abuse
- history of sleep apnea
- episode(s) of confusion, disorientation during this admission
- episode(s) of respiratory depression during this admission
- history of major psychiatric disorder pregnancy
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
University Health Network
Toronto, Ontario, M5T 2S8
Universtiy Health Network
Toronto, Ontario, M5T 2S8
About this study
Official title: Patient Controlled Oral Analgesia (PCOA) for Postoperative Pain Management After Total Knee Replacement-A Pilot Study
Patient Centered Care (PCC) is "an approach that consciously adopts the patient's perspective...about what matters" (Gerteis, Edgeman, Levitan, Walker, Stokes, Cleary, Delbanco, 1993). Experiencing pain is the most common concern of patients before surgery - even ahead of whether the surgery would improve their condition (Apfelbaum, 2003). Current standard of practice for post-operative pain management in most acute care hospitals today is intravenous patient controlled analgesia (IV PCA). However, despite the fact that patients prefer IV PCA because it affords them greater control and provides them with better pain relief (Ballantyne, Carr, deFerranti, Suarez, Lau, Chalmers, Angelillo, Mosteller, 1998 ; Rawal, 2001), hospitals routinely take control of pain medications away from patients once they are switched to pain tablets. Patients must then wait, in pain, for their nurse to bring them pain tablets.
Patient controlled oral analgesia (PCOA) has been utilitzed in several centers in the US and Germany. Preliminary evidence from the literature seems to indicate that the benefits of PCOA are similar to IV PCA including increased patient satisfaction and better pain control (Striebel, Romer, Kopf, Schwagmeier ,1996; Striebel, Scheitza, Philippi, Behrens, Toussaint, 1998). At the Toronto Western Hospital, University Health Network, we have successfully implemented a PCOA program on two surgical units (Orthopedics/Rheumatology and Spinal). The purpose of this study is to compare usual nurse administered oral analgesia to PCOA with respect to pain, patient satisfaction, and passive range of knee motion in postoperative total knee replacement patients.
- Being tested
- Self-administration or nurse administered medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administration or nurse administered medicationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-Administered Versus Nurse Administered Pain Medication.Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Patti Kastanias, RN, MSc(A), ACNP, Principal investigator, University of Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221936
- Sponsor's protocol ID
- UHN04-0394-AE
- Status last verified
- Jul 2005
- First submitted
- 20 Sep 2005
- Last updated
- 5 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Controlled Oral Analgesia (PCOA) for Postoperative Pain Management After Total Knee Replacement-A Pilot Study
- ClinicalTrials.gov ID
- NCT00221936
- Acronym / sponsor ID
- UHN04-0394-AE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 22 Sep 2005 (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.
Patient Centered Care (PCC) is "an approach that consciously adopts the patient's perspective...about what matters" (Gerteis, Edgeman, Levitan, Walker, Stokes, Cleary, Delbanco, 1993). Experiencing pain is the most common concern of patients before surgery - even ahead of whether the surgery would improve their condition (Apfelbaum, 2003). Current standard of practice for post-operative pain management in most acute care hospitals today is intravenous patient controlled analgesia (IV PCA). However, despite the fact that patients prefer IV PCA because it affords them greater control and provides them with better pain relief (Ballantyne, Carr, deFerranti, Suarez, Lau, Chalmers, Angelillo, Mosteller, 1998 ; Rawal, 2001), hospitals routinely take control of pain medications away from patients once they are switched to pain tablets. Patients must then wait, in pain, for their nurse to bring them pain tablets.
Patient controlled oral analgesia (PCOA) has been utilitzed in several centers in the US and Germany. Preliminary evidence from the literature seems to indicate that the benefits of PCOA are similar to IV PCA including increased patient satisfaction and better pain control (Striebel, Romer, Kopf, Schwagmeier ,1996; Striebel, Scheitza, Philippi, Behrens, Toussaint, 1998). At the Toronto Western Hospital, University Health Network, we have successfully implemented a PCOA program on two surgical units (Orthopedics/Rheumatology and Spinal). The purpose of this study is to compare usual nurse administered oral analgesia to PCOA with respect to pain, patient satisfaction, and passive range of knee motion in postoperative total knee replacement patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- able to read and write English
- post elective total knee replacement surgery (primary or revision)
- already on IV PCA
- age 18-80
- able to tolerate oral medication
Key exclusion criteria (5 listed)
- history of substance abuse
- history of sleep apnea
- episode(s) of confusion, disorientation during this admission
- episode(s) of respiratory depression during this admission
- history of major psychiatric disorder pregnancy
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 |
|---|---|---|
| Self-administration or nurse administered medication | Behavioural | – |
Primary outcome
Not reported in the source record.
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 5 Dec 2008.
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.
Patti Kastanias, RN, MSc(A), ACNP principal investigator
University of Health Network, Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administration or nurse administered medication in people with Self-Administered Versus Nurse Administered Pain Medication., run by University Health Network, Toronto at 3 sites 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 7 inclusion and 5 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 5 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
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 5 Dec 2008.