Self-Administered Versus Nurse Administered Pain Medication. Clinical Trial
Official title:
Patient Controlled Oral Analgesia (PCOA) for Postoperative Pain Management After Total Knee Replacement-A Pilot Study
| Verified date | July 2005 |
| Source | University Health Network, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: UHNToronto |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | July 2005 |
| Est. primary completion date | July 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Toronto Western Hospital | Toronto | Ontario |
| Canada | University Health Network | Toronto | Ontario |
| Canada | Universtiy Health Network | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University Health Network, Toronto |
Canada,