Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Morphine PCA
Hydromorphone PCA
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring pain, morphine, hydromorphone, nausea, vomiting, pruritis
Eligibility Criteria
Inclusion Criteria:
- patients scheduled for abdominal surgery requiring post-operative PCA
- ASA = I or II
Exclusion Criteria:
- preoperative pain or use of pain medication
- narcotic allergy
- morbid obesity (Body Mass Index > 30)
- diagnosis of sleep apnea
- hepatic or renal disease
- use of medications that would affect narcotic pharmacodynamics
- preoperative nausea, vomiting, or pruritis
- diagnosis of alcoholism
Sites / Locations
- Columbia Presbyterian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.
Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.
Outcomes
Primary Outcome Measures
Nausea Assessment by Patient
Nausea scale range: (0 = none, 10 = the worst), ordinal.
Secondary Outcome Measures
Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale
The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).
Pain Assessment by Patient
Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.
The Number of Patients Who Vomited
Mean Score on the Ramsey Scale of Sedation
The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00385541
Brief Title
Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
Official Title
The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2003 (Actual)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
pain, morphine, hydromorphone, nausea, vomiting, pruritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.
Intervention Type
Drug
Intervention Name(s)
Morphine PCA
Other Intervention Name(s)
Astramorph PF, Duramorph, Infumorph
Intervention Description
Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
Intervention Type
Drug
Intervention Name(s)
Hydromorphone PCA
Other Intervention Name(s)
Dilaudid
Intervention Description
hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
Primary Outcome Measure Information:
Title
Nausea Assessment by Patient
Description
Nausea scale range: (0 = none, 10 = the worst), ordinal.
Time Frame
1 hour after surgery, 8 hours after surgery
Secondary Outcome Measure Information:
Title
Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale
Description
The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).
Time Frame
1 hour after surgery, 8 hours after surgery
Title
Pain Assessment by Patient
Description
Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.
Time Frame
1 hour after surgery, 8 hours after surgery
Title
The Number of Patients Who Vomited
Time Frame
1 hour after surgery, 8 hours after surgery
Title
Mean Score on the Ramsey Scale of Sedation
Description
The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).
Time Frame
1 hour after surgery, 8 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients scheduled for abdominal surgery requiring post-operative PCA
ASA = I or II
Exclusion Criteria:
preoperative pain or use of pain medication
narcotic allergy
morbid obesity (Body Mass Index > 30)
diagnosis of sleep apnea
hepatic or renal disease
use of medications that would affect narcotic pharmacodynamics
preoperative nausea, vomiting, or pruritis
diagnosis of alcoholism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Flood, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18806056
Citation
Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9. doi: 10.1213/ane.0b013e3181823efb.
Results Reference
result
Learn more about this trial
Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
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