Pain ManagementPhase 4NCT00880607
Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion
A Phase 4 study testing Intrathecal morphine and Extended Release Epidural Morphine in people with Pain Management and Spinal Fusion, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Pain Management, Spinal Fusion, Scoliosis
- What is being tested?
- Intrathecal morphine and Extended Release Epidural Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and females, 8 to17 years old undergoing posterior spinal fusion for idiopathic scoliosis.
- Fusion of a minimum of 5, and a maximum of 13 levels, including at least L1 or lower.
Who cannot join
- Neuromuscular scoliosis.
- A history of documented coagulopathy or platelet count of less than 100,000 mm3.
- A known allergy or adverse sensitivity to morphine.
- Pulmonary hypertension or other significant respiratory problem.
- Cognitive deficits that would impair use of PCA and/or filling out questionnaire.
- History of sleep apnea defined by sleep study and/or need for nighttime CPAP.
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- Abnormal pain thresholds (i.e., subjects who are on significant opioids preoperatively).
- Baseline neurologic deficits (numbness, motor deficits, or any focal neurological sign).
- Subjects who are anticipated to remain intubated postoperatively for longer than 2 hours.
- Need for preoperative intravenous inotropic drugs.
- Significant metabolic, endocrine or neuropathology, cyanosis, or renal insufficiency.
- A contraindication to dural puncture, such as raised intracranial pressure.
- Pre-operative heparin, oral aspirin or anticoagulants.
- Weight less than 20kg or greater than 100kg.
- Need for Intraoperative ketamine administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital- Denver
Aurora, Colorado, 80045
About this study
Official title: The Use of Intraoperative Intrathecal Morphine Versus Epidural Extended Release Morphine for Postoperative Pain Control in Pediatric Patients Undergoing Posterior Spinal Fusion
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.
Read the 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.
- Conditions
- Pain Management, Spinal Fusion, Scoliosis
- Being tested
- Intrathecal morphine, Extended Release Epidural Morphine
- Keywords
- Pain, Pediatric, Spinal Fusion, pain management
- Medical subject headings
- Agnosia, Scoliosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphineDrug
Also called IT 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.
Extended Release Epidural MorphineDrug
Also called EREM, 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.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine | Active comparator | Receives a single dose of intrathecal morphine Receives: Drug: Intrathecal morphine |
| Extended Release Epidural Morphine | Experimental | Receives DepoDur extended release epidural morphine for pain management Receives: Drug: Extended Release Epidural Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four hour intervals for up to 48 hours
Secondary outcomes (6)
Time Until First PCA Demand Request
At 4-hour intervals for up to 48 hours IV PCA demands.
Measured: every 4 hours up to 48 hours
Post-operative Pain Scores
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.
Measured: every 4 hours up to 48 hours
Adverse Opioid Effect: Nausea
presence of nausea- dichotomous variable
Measured: every 4 hours up to 48 hours
Adverse Opioid Effect: Emesis
presence of emesis- dichotomous variable
Measured: every 4 hours up to 48 hours
Adverse Opioid Effect: Pruritus
presence of pruritus- dichotomous variable
Measured: every 4 hours up to 48 hours
Adverse Opioid Effect: Respiratory Depression
presence of respiratory depression- dichotomous variable
Measured: every 4 hours up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mindy Cohen, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880607
- Sponsor's protocol ID
- 08-0721
- Other IDs
- Seed grant UCHSC
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2009
- Last updated
- 22 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intraoperative Intrathecal Morphine Versus Epidural Extended Release Morphine for Postoperative Pain Control in Pediatric Patients Undergoing Posterior Spinal Fusion
- ClinicalTrials.gov ID
- NCT00880607
- Acronym / sponsor ID
- 08-0721
- Conditions
- Pain Management, Spinal Fusion, Scoliosis
- Keywords
- Pain, Pediatric, Spinal Fusion, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Posted 22 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine | Active comparator | Drug: Intrathecal morphineReceives a single dose of intrathecal morphine |
| Extended Release Epidural Morphine | Experimental | Drug: Extended Release Epidural MorphineReceives DepoDur extended release epidural morphine for pain management |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and females, 8 to17 years old undergoing posterior spinal fusion for idiopathic scoliosis.
- Fusion of a minimum of 5, and a maximum of 13 levels, including at least L1 or lower.
Key exclusion criteria (15 listed)
- Neuromuscular scoliosis.
- A history of documented coagulopathy or platelet count of less than 100,000 mm3.
- A known allergy or adverse sensitivity to morphine.
- Pulmonary hypertension or other significant respiratory problem.
- Cognitive deficits that would impair use of PCA and/or filling out questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal morphineAlso: IT MorphineMorphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain. | Drug | Intrathecal morphine |
| Extended Release Epidural MorphineAlso: EREM, DepoDurDepoDur™ 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. | Drug | Extended Release Epidural Morphine |
Primary outcome
Total IV Morphine Consumption up to 48 Hours Post Surgery
Time frame: 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.
6 secondary outcomes
Time Until First PCA Demand Request
Time frame: every 4 hours up to 48 hours
Post-operative Pain Scores
Time frame: every 4 hours up to 48 hours
Adverse Opioid Effect: Nausea
Time frame: every 4 hours up to 48 hours
Adverse Opioid Effect: Emesis
Time frame: every 4 hours up to 48 hours
Adverse Opioid Effect: Pruritus
Time frame: every 4 hours up to 48 hours
Adverse Opioid Effect: Respiratory Depression
Time frame: every 4 hours up to 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mindy Cohen, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal morphine and Extended Release Epidural Morphine in people with Pain Management and Spinal Fusion, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total IV Morphine Consumption up to 48 Hours Post Surgery (time frame: Four hour intervals for up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.