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Patient-controlled intravenous analgesia (PCA) has already proven its quality. However, with new strategies starting to emerge and the current concept of opioid sparing, it is a goal to find the optimal PCA strategy capable of improve patient satisfaction and, at the same time, individualize opioid dose.
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System with intravenous PCA Morphine in terms of postoperative pain control satisfaction, total dose of opioid required, adverse effects, impact on the quality of postoperative recovery and the incidence of postoperative chronic pain.
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System (15mcg per tablet, 20 minutes lockout) with intravenous PCA Morphine based on 1mg morphine on-demand 10 minutes lockout and a baseline perfusion of 1mg/hour.
45 patients capable of comply a PCA regime submitted to total knee arthroplasty, total hip arthroplasty and abdominal hysterectomy were enrolled in the study. During the first 48 hours, it was accessed daily pain scores, PCA use, need for rescue therapy, adverse effects, global satisfaction as well as postoperative quality recovery. Brief Pain Inventory was performed before surgery and 4 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil Sublingual Tablet System | Experimental | Group treated with Sufentanil Sublingual Tablet System |
|
| Intravenous Patient-Controlled Analgesia with Morphine | Experimental | Group treated with intravenous Patient-Controlled Analgesia with Morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil Sublingual Tablet System | Drug | Sufentanil Sublingual Tablet System is a sublingual opioid patient controlled analgesia system. It was used for postoperative analgesia after surgery associated with moderate to severe pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain control | Comparison between patient controlled analgesia with IV morphine and sublingual sufentanil in Numeric Rating Scale | Evaluation at 24 hours and 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects associated with analgesia | Evaluation of adverse effects of the PCA systems: sedation using the Richamond Agitation Sedation Scale (RASS); hypoxemia without oxygen supplementation: mild to moderate (SpO2 90-93%) or severe (SpO2<90%); hypotension; nausea or vomiting; dyspepsia; itching | Evaluation at 24 hours and 48 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana IPG Pereira, Medical | Hospital Central do Funchal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Central do Funchal | Funchal | Madeira | 9000-177 | Portugal |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| D017060 | Patient Satisfaction |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Intravenous Patient-Controlled Analgesia with morfine | Drug | Intravenous Patient-Controlled Analgesia with morfine. It was used for postoperative analgesia after surgery associated with moderate to severe pain. |
|
| Total daily dose of opioid | Evaluation of total daily dose of each drug | Evaluation at 24 hours and 48 hours after surgery |
| Patients satisfaction with analgesia | Evaluation of patient satisfaction using a qualitative scale: "Poor"; "Average"; "Good"; "Excellent" | Evaluation at 24 hours and 48 hours after surgery |
| Impact of the treatment on the quality of postoperative recovery | Evaluation of recovery with application of validated quality of recovery score (QoR-15) questionnaire | Evaluation at 24 hours after surgery |
| Incidence of postoperative chronic pain | Assessment to persistent postoperative pain by completing the Brief Pain Inventory | 4 months after surgey |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |