Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion

The Use of Intraoperative Intrathecal Morphine Versus Epidural Extended Release Morphine for Postoperative Pain Control in Pediatric Patients Undergoing Posterior Spinal Fusion

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00880607

Enrollment

Registered

2009-04-14

Start date

2008-12-31

Completion date

2012-09-30

Last updated

2020-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management, Scoliosis, Spinal Fusion

Keywords

Pain, Pediatric, Spinal Fusion, pain management

Brief summary

This study plans to learn more about preventing pain in children who are having posterior spinal fusion surgery using two different kinds of morphine (a pain medicine). Also, this study plans to learn about individual differences in the how the different kinds of morphine work in children. Subjects are being asked to be in this research study because they are having spinal fusion surgery, will have pain some of the time and will be getting morphine during and after surgery to help control their pain.

Detailed description

Up to 80 people from Denver will participate in the study. Subjects will be randomized to receive one of two possible medications during surgery to help with pain after surgery. After they go to sleep for surgery the anesthesiologist will give them either (1) a single injection of morphine into the spinal fluid in the lower back, or (2) a single injection of extended-release morphine into the epidural space (just outside the spinal fluid) in the lower back. The usual care for patients having this surgery is a single injection of morphine into the spinal fluid in the lower back. If randomized to group (1), subjects will receive the usual care for pain control. If subjects are randomized to group (2), they will receive a single injection of extended-release morphine into the epidural space. During surgery, a small blood sample (1 teaspoon or less) will be collected to analyze specific DNA sequences that are involved in individual responses to morphine for pain control. The blood sample will be destroyed after 24 months. After surgery, subjects will have IV pain medication through a patient-controlled analgesia (PCA) machine. Subjects will be shown how to work the PCA so they can get the pain medicine when they need it. A research nurse will check in frequently to ask how much pain is occurring following the surgery and any side effects that may arise from the study medicine. Subjects will be in this study up to 60 hours after surgery.

Interventions

DRUGIntrathecal 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.

DRUGExtended Release Epidural Morphine

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

8 Years to 17 Years

Healthy volunteers

Inclusion criteria

1. Male and females, 8 to17 years old undergoing posterior spinal fusion for idiopathic scoliosis. 2. Fusion of a minimum of 5, and a maximum of 13 levels, including at least L1 or lower.

Exclusion criteria

1. Neuromuscular scoliosis. 2. A history of documented coagulopathy or platelet count of less than 100,000 mm3. 3. A known allergy or adverse sensitivity to morphine. 4. Pulmonary hypertension or other significant respiratory problem. 5. Cognitive deficits that would impair use of PCA and/or filling out questionnaire. 6. History of sleep apnea defined by sleep study and/or need for nighttime CPAP. 7. Abnormal pain thresholds (i.e., subjects who are on significant opioids preoperatively). 8. Baseline neurologic deficits (numbness, motor deficits, or any focal neurological sign). 9. Subjects who are anticipated to remain intubated postoperatively for longer than 2 hours. 10. Need for preoperative intravenous inotropic drugs. 11. Significant metabolic, endocrine or neuropathology, cyanosis, or renal insufficiency. 12. A contraindication to dural puncture, such as raised intracranial pressure. 13. Pre-operative heparin, oral aspirin or anticoagulants. 14. Weight less than 20kg or greater than 100kg. 15. Need for Intraoperative ketamine administration.

Design outcomes

Primary

Measure	Time frame	Description
Total IV Morphine Consumption up to 48 Hours Post Surgery	Four hour intervals for up to 48 hours	Total IV morphine consumption during the first 0- 48 hours after surgery.Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen.

Secondary

Measure	Time frame	Description
Post-operative Pain Scores	every 4 hours up to 48 hours	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.
Adverse Opioid Effect: Nausea	every 4 hours up to 48 hours	presence of nausea- dichotomous variable
Time Until First PCA Demand Request	every 4 hours up to 48 hours	At 4-hour intervals for up to 48 hours IV PCA demands.
Adverse Opioid Effect: Pruritus	every 4 hours up to 48 hours	presence of pruritus- dichotomous variable
Adverse Opioid Effect: Respiratory Depression	every 4 hours up to 48 hours	presence of respiratory depression- dichotomous variable
Adverse Opioid Effect: Emesis	every 4 hours up to 48 hours	presence of emesis- dichotomous variable

Countries

United States

Participant flow

Recruitment details

84 patients consented to participate. 3 patients did not start the study due to physician discretion.

Participants by arm

Arm	Count
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.	37
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.	34
Total	71

Withdrawals & dropouts

Period	Reason	FG000	FG001
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

Characteristic	Total	Intrathecal Morphine	DepoDur
Age, Continuous	14.0 years STANDARD_DEVIATION 1.9	13.8 years STANDARD_DEVIATION 1.9	14.2 years STANDARD_DEVIATION 1.9
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	3 Participants	3 Participants	0 Participants
Race (NIH/OMB) More than one race	9 Participants	5 Participants	4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	58 Participants	29 Participants	29 Participants
Region of Enrollment United States	71 participants	37 participants	34 participants
Sex: Female, Male Female	55 Participants	28 Participants	27 Participants
Sex: Female, Male Male	16 Participants	9 Participants	7 Participants
Weight	54.4 kg STANDARD_DEVIATION 11.2	53.6 kg STANDARD_DEVIATION 12	55.2 kg STANDARD_DEVIATION 10.44

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 37	0 / 34
other Total, other adverse events	0 / 37	0 / 34
serious Total, serious adverse events	0 / 37	0 / 34

Outcome results

Primary

Total IV Morphine Consumption up to 48 Hours Post Surgery

Total IV morphine consumption during the first 0- 48 hours after surgery.Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen.

Time frame: Four hour intervals for up to 48 hours

Population: 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.

Arm	Measure	Value (MEDIAN)
Intrathecal Morphine	Total IV Morphine Consumption up to 48 Hours Post Surgery	34.0 mg
EREM	Total IV Morphine Consumption up to 48 Hours Post Surgery	42.2 mg

p-value: 0.2795% CI: [-5.8, 21.2]Wilcoxon (Mann-Whitney)

Secondary