Trial Outcomes & Findings for Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion (NCT NCT00880607)
NCT ID: NCT00880607
Last Updated: 2020-04-22
Results Overview
Total IV morphine consumption during the first 0- 48 hours after surgery.Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
84 participants
Primary outcome timeframe
Four hour intervals for up to 48 hours
Results posted on
2020-04-22
Participant Flow
84 patients consented to participate. 3 patients did not start the study due to physician discretion.
Participant milestones
| Measure |
Intrathecal Morphine
Receives a single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
DepoDur
Receives DepoDur extended release morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
37
|
|
Overall Study
Observation After Receiving Medication
|
42
|
35
|
|
Overall Study
COMPLETED
|
37
|
34
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Intrathecal Morphine
Receives a single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
DepoDur
Receives DepoDur extended release morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
surgery did not extend past L1 level
|
3
|
0
|
Baseline Characteristics
Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion
Baseline characteristics by cohort
| Measure |
Intrathecal Morphine
n=37 Participants
Receives a single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
DepoDur
n=34 Participants
Receives DepoDur extended release morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.8 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
14.2 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
14.0 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
34 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Weight
|
53.6 kg
STANDARD_DEVIATION 12.0 • n=5 Participants
|
55.2 kg
STANDARD_DEVIATION 10.44 • n=7 Participants
|
54.4 kg
STANDARD_DEVIATION 11.20 • n=5 Participants
|
PRIMARY outcome
Timeframe: Four hour intervals for up to 48 hoursPopulation: Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.
Total IV morphine consumption during the first 0- 48 hours after surgery.Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen.
Outcome measures
| Measure |
Intrathecal Morphine
n=37 Participants
single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
EREM
n=34 Participants
Receives extended release epidural morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
|---|---|---|
|
Total IV Morphine Consumption up to 48 Hours Post Surgery
|
34.0 mg
Interval 4.5 to 128.8
|
42.2 mg
Interval 5.5 to 123.0
|
SECONDARY outcome
Timeframe: every 4 hours up to 48 hoursPopulation: Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.
At 4-hour intervals for up to 48 hours IV PCA demands.
Outcome measures
| Measure |
Intrathecal Morphine
n=34 Participants
single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
EREM
n=30 Participants
Receives extended release epidural morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
|---|---|---|
|
Time Until First PCA Demand Request
|
0.99 hours
Interval 0.75 to 1.15
|
0.92 hours
Interval 0.5833 to 1.4333
|
SECONDARY outcome
Timeframe: every 4 hours up to 48 hoursPopulation: Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.
Post-operative pain scores using Bieri faces scale every 4 hours up to 48 hours. Using Bieri faces pain scale. The faces show how much something can hurt. The "happy face" with a smile is no pain = 0 to faces showing more and more pain up 10. The space between two faces is scored 1, 3,5,7, or 9. to 10 (worst pain) will be used every 4 hours post-op for up to 48 hours. \*Scores were not collected and/or included for all participants at all time points. If a patient was sleeping, there score was not recorded. If a patient completed the pain scale incorrectly (used an even number or included a range), then the data point was not included.
Outcome measures
| Measure |
Intrathecal Morphine
n=37 Participants
single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
EREM
n=34 Participants
Receives extended release epidural morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
|---|---|---|
|
Post-operative Pain Scores
0 hours
|
3.26 units on a scale
Standard Error 0.53
|
6.69 units on a scale
Standard Error 0.60
|
|
Post-operative Pain Scores
4 hours
|
2.70 units on a scale
Standard Error 0.38
|
4.03 units on a scale
Standard Error 0.46
|
|
Post-operative Pain Scores
8 hours
|
2.25 units on a scale
Standard Error 0.36
|
2.88 units on a scale
Standard Error 0.43
|
|
Post-operative Pain Scores
12 hours
|
2.96 units on a scale
Standard Error 0.37
|
2.19 units on a scale
Standard Error 0.44
|
|
Post-operative Pain Scores
16 hours
|
4.13 units on a scale
Standard Error 0.45
|
3.03 units on a scale
Standard Error 0.38
|
|
Post-operative Pain Scores
20 hours
|
3.61 units on a scale
Standard Error 0.35
|
2.80 units on a scale
Standard Error 0.34
|
|
Post-operative Pain Scores
24 hours
|
3.10 units on a scale
Standard Error 0.40
|
3.17 units on a scale
Standard Error 0.36
|
|
Post-operative Pain Scores
32 hours
|
3.83 units on a scale
Standard Error 0.45
|
2.81 units on a scale
Standard Error 0.34
|
|
Post-operative Pain Scores
36 hours
|
3.85 units on a scale
Standard Error 0.57
|
2.86 units on a scale
Standard Error 0.35
|
|
Post-operative Pain Scores
40 hours
|
3.92 units on a scale
Standard Error 0.48
|
3.09 units on a scale
Standard Error 0.43
|
|
Post-operative Pain Scores
44 hours
|
3.63 units on a scale
Standard Error 0.42
|
3.10 units on a scale
Standard Error 0.36
|
|
Post-operative Pain Scores
48 hours
|
3.41 units on a scale
Standard Error 0.37
|
3.77 units on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: every 4 hours up to 48 hoursPopulation: Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.
presence of nausea- dichotomous variable
Outcome measures
| Measure |
Intrathecal Morphine
n=37 Participants
single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
EREM
n=34 Participants
Receives extended release epidural morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
|---|---|---|
|
Adverse Opioid Effect: Nausea
|
46 percentage of patients with nausea
|
26 percentage of patients with nausea
|
SECONDARY outcome
Timeframe: every 4 hours up to 48 hoursPopulation: Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.
presence of emesis- dichotomous variable
Outcome measures
| Measure |
Intrathecal Morphine
n=37 Participants
single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
EREM
n=34 Participants
Receives extended release epidural morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
|---|---|---|
|
Adverse Opioid Effect: Emesis
|
24 percentage of patients with emesis
|
15 percentage of patients with emesis
|
SECONDARY outcome
Timeframe: every 4 hours up to 48 hoursPopulation: Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.
presence of pruritus- dichotomous variable
Outcome measures
| Measure |
Intrathecal Morphine
n=37 Participants
single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
EREM
n=34 Participants
Receives extended release epidural morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
|---|---|---|
|
Adverse Opioid Effect: Pruritus
|
81 percentage of patients with pruritus
|
62 percentage of patients with pruritus
|
SECONDARY outcome
Timeframe: every 4 hours up to 48 hoursPopulation: Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.
presence of respiratory depression- dichotomous variable
Outcome measures
| Measure |
Intrathecal Morphine
n=37 Participants
single dose of intrathecal morphine
Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
|
EREM
n=34 Participants
Receives extended release epidural morphine for pain management
DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
|
|---|---|---|
|
Adverse Opioid Effect: Respiratory Depression
|
24 % patients with respiratory depression
|
15 % patients with respiratory depression
|
Adverse Events
Intrathecal Morphine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DepoDur
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mindy Cohen, MD FAAP, Assistant Professor, Department of Anesthesiology
Children's Hospital of Colorado, University of Colorado
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place