Post Operative Pain
Conditions
Keywords
pain, morphine, hydromorphone, nausea, vomiting, pruritis
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
Interventions
DRUGMorphine PCA
Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Assessment by Patient | 1 hour after surgery, 8 hours after surgery | Nausea scale range: (0 = none, 10 = the worst), ordinal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale | 1 hour after surgery, 8 hours after surgery | The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst). |
| Pain Assessment by Patient | 1 hour after surgery, 8 hours after surgery | Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal. |
| The Number of Patients Who Vomited | 1 hour after surgery, 8 hours after surgery | — |
| Mean Score on the Ramsey Scale of Sedation | 1 hour after surgery, 8 hours after surgery | 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). |
Countries
United States
Participant flow
Recruitment details
Adults having general surgery at Columbia University Medical Center (CUMC) were randomly assigned to receive Patient-Controlled Analgesia (PCA) with morphine or hydromorphone
Pre-assignment details
Double blind randomized controlled trial. Patients under 18, with chronic pain or on pain medication before surgery were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Morphine PCA Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes | 25 |
| Hydromorphone PCA Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | severe pain, clinician requested unblind | 0 | 1 |
Baseline characteristics
| Characteristic | Hydromorphone PCA | Morphine PCA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 8 | 42 years STANDARD_DEVIATION 12 | 42.6 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Nausea Assessment by Patient
Nausea scale range: (0 = none, 10 = the worst), ordinal.
Time frame: 1 hour after surgery, 8 hours after surgery
Population: Intention to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morphine PCA | Nausea Assessment by Patient | 4.6 Units on a scale | Standard Deviation 3.2 |
| Hydromorphone PCA | Nausea Assessment by Patient | 3.0 Units on a scale | Standard Deviation 2.5 |
Secondary
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).
Time frame: 1 hour after surgery, 8 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morphine PCA | Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale | 2 Units on a scale | Standard Deviation 0 |
| Hydromorphone PCA | Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale | 2.5 Units on a scale | Standard Deviation 1.3 |
Secondary
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).
Time frame: 1 hour after surgery, 8 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morphine PCA | Mean Score on the Ramsey Scale of Sedation | 2.8 score on scale | Standard Deviation 0.6 |
| Hydromorphone PCA | Mean Score on the Ramsey Scale of Sedation | 2.8 score on scale | Standard Deviation 0.7 |
Secondary
Pain Assessment by Patient
Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.
Time frame: 1 hour after surgery, 8 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morphine PCA | Pain Assessment by Patient | 7.9 Units on a scale | Standard Deviation 2.3 |
| Hydromorphone PCA | Pain Assessment by Patient | 7.1 Units on a scale | Standard Deviation 2.4 |
Secondary
The Number of Patients Who Vomited
Time frame: 1 hour after surgery, 8 hours after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Morphine PCA | The Number of Patients Who Vomited | 1 participants |
| Hydromorphone PCA | The Number of Patients Who Vomited | 0 participants |