Does IVPCA Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
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|ClinicalTrials.gov Identifier: NCT02880800|
Recruitment Status : Unknown
Verified August 2016 by Naveed Siddiqui, Mount Sinai Hospital, Canada.
Recruitment status was: Recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Morphine as IVPCA Drug: Hydromorphone as IVPCA Drug: Morphine Drug: Hydromorphone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2017|
Experimental: Analgesia, patient controlled
Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone.
Drug: Morphine as IVPCA
Morphine as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of morphine as below:
Morphine bolus 1mg with a lockout interval of 5 minutes, no background infusion and maximum 30 mg in 4 hours
Other Name: Morphine
Drug: Hydromorphone as IVPCA
Hydromorphone as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of Hydromorphone as below:
Hydromorphone bolus 0.2 mg with a lockout interval of 5 minutes and a maximum dose of 6 mg in 4 hours.
Other Name: Dilaudid
Active Comparator: Analgesia, as per needed
Patients will receive intravenous (IV) opioids as per needed.
IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)
Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)
Other Name: Dilaudid
- Total amount of opioid consumption postoperatively [ Time Frame: Every 24 hours for up to 48 hours after randomization ]
- Opioid related side effects. [ Time Frame: Every 24 hours for up to 48 hours after randomization ]Opioid-related Symptom Distress Scale Questionnaire
- Patient satisfaction [ Time Frame: Once at 48 hours after randomization ]
Patient satisfaction scale as below:
- Very dissatisfied
- Slightly dissatisfied
- Slightly satisfied
- Very satisfied
- Pain scores measured at rest and movement [ Time Frame: Every 12 hours for up to 48 hours after randomization ]Based on verbal analogue scale (VAS) scoring system (0-10), where score of 0 refers to no pain and a score of 10 refers to the worst pain imaginable
- Length of stay in hospital [ Time Frame: One week ]The total number of days the study patient was admitted in the hospital for a medical reason
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880800
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Contact: Naveed Siddiqui 416-586-5270 firstname.lastname@example.org|