ScoliosisPhase 3NCT02558010
Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
A Phase 3 study testing Methadone, Normal Saline and Morphine in people with Scoliosis and Pain, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions. Spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- What is being tested?
- Methadone, Normal Saline and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 1 Jan 2023
- Phase
- Phase 3
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 10-18 years
- Idiopathic scoliosis
- Fusion levels planned for 10 or greater
- English speaking
- American Society of Anesthesiology (ASA) class 1 - 3
Who cannot join
- Current narcotic use / History of substance use disorder
- Morphine, hydromorphone or methadone allergies
- Pregnancy
- Seizure disorders
- Bleeding disorders
- Neuromuscular scoliosis
Show all 12Show fewer
- History of renal or hepatic disease
- Long QT syndrome
- Obstructive sleep apnea
- Body mass index > 40
- Inability to tolerate standard analgesic medications (gabapentin, ketorolac, acetaminophen)
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions.
Spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. While the standard management of post-surgical pain involves a multimodal approach, opioids provide the predominant benefit. However, opioid use is associated with many adverse effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease total opioid consumption and adverse effects as well as improve satisfaction with pain management after scoliosis repair.
Read the detailed description
This study is a double blind comparison, evaluating the benefits of intraoperative methadone in extensive posterior spine fusion surgery for idiopathic scoliosis. Methadone 0.2 mg/kg will be given to the treatment group. Postoperative evaluation for narcotic use, pain control, and adverse effects will be compared to a standard treatment approach used at Children's Hospital of Wisconsin.
- Being tested
- Methadone, Normal Saline, Morphine
- Keywords
- Methadone, Gabapentin, Postoperative Pain, Posterior Spinal Fusion, Pediatric
- Medical subject headings
- Scoliosis, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Also called generic methadone
Perioperative IV methadone to be given
Normal SalineOther
Also called salt water
control arm
MorphineDrug
Also called Duramorph
Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
| Study group | Role | What they receive |
|---|---|---|
| Methadone Group | Experimental | Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg. Receives: Drug: Methadone; Drug: Morphine |
| Control Group | Active comparator | Patient will receive normal saline placebo initially, then morphine prior to emergence. Receives: Other: Normal Saline; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Opioid Consumption (mg/kg)
Total amount of opioids consumed during the first 72 hours after surgery.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study start1 Feb 2016
- Primary completion1 Jan 2022
- Study completion1 Jan 2023
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keri Hainsworth, Medical College of Wisconsin
- Investigators
- Steven Weisman, MD, Study chair, Children's Hospital and Health System Foundation, WisconsinRoger A Fons, MD, Principal investigator, Children's Hospital and Health System Foundation, Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558010
- Sponsor's protocol ID
- CHW-Methadone-001
- Status last verified
- Nov 2023
- First submitted
- 13 Feb 2015
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Berde CB, Beyer JE, Bournaki MC, Levin CR, Sethna NF. Comparison of morphine and methadone for prevention of postoperative pain in 3- to 7-year-old children. J Pediatr. 1991 Jul;119(1 Pt 1):136-41. doi: 10.1016/s0022-3476(05)81054-6.
PubMed 2066846Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
PubMed 20418538Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
PubMed 20418301Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.
PubMed 22037641
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
- ClinicalTrials.gov ID
- NCT02558010
- Acronym / sponsor ID
- CHW-Methadone-001
- Keywords
- Methadone, Gabapentin, Postoperative Pain, Posterior Spinal Fusion, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Posted 27 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions.
Spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. While the standard management of post-surgical pain involves a multimodal approach, opioids provide the predominant benefit. However, opioid use is associated with many adverse effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease total opioid consumption and adverse effects as well as improve satisfaction with pain management after scoliosis repair.
Detailed description
This study is a double blind comparison, evaluating the benefits of intraoperative methadone in extensive posterior spine fusion surgery for idiopathic scoliosis. Methadone 0.2 mg/kg will be given to the treatment group. Postoperative evaluation for narcotic use, pain control, and adverse effects will be compared to a standard treatment approach used at Children's Hospital of Wisconsin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone Group | Experimental | Drug: Methadone, Drug: MorphinePatients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg. |
| Control Group | Active comparator | Other: Normal Saline, Drug: MorphinePatient will receive normal saline placebo initially, then morphine prior to emergence. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 10-18 years
- Idiopathic scoliosis
- Fusion levels planned for 10 or greater
- English speaking
- American Society of Anesthesiology (ASA) class 1 - 3
Key exclusion criteria (12 listed)
- Current narcotic use / History of substance use disorder
- Morphine, hydromorphone or methadone allergies
- Pregnancy
- Seizure disorders
- Bleeding disorders
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 |
|---|---|---|
| MethadoneAlso: generic methadonePerioperative IV methadone to be given | Drug | Methadone Group |
| Normal SalineAlso: salt watercontrol arm | Other | Control Group |
| MorphineAlso: DuramorphBoth groups will receive morphine via Patient-Controlled Analgesia (PCA) pump. | Drug | Control Group, Methadone Group |
Primary outcome
Post-operative Opioid Consumption (mg/kg)
Time frame: 72 hours
Total amount of opioids consumed during the first 72 hours after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2066846Berde CB, Beyer JE, Bournaki MC, Levin CR, Sethna NF. Comparison of morphine and methadone for prevention of postoperative pain in 3- to 7-year-old children. J Pediatr. 1991 Jul;119(1 Pt 1):136-41. doi: 10.1016/s0022-3476(05)81054-6.
- Background: PubMed 20418538Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
- Background: PubMed 20418301Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
- Background: PubMed 22037641Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.
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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.
Steven Weisman, MD study chair
Children's Hospital and Health System Foundation, Wisconsin
Roger A Fons, MD principal investigator
Children's Hospital and Health System Foundation, Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone, Normal Saline and Morphine in people with Scoliosis and Pain, run by Medical College of Wisconsin 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 5 inclusion and 12 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 18 Nov 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 27 Apr 2023). 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?
Post-operative Opioid Consumption (mg/kg) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02558010, which also lists 4 linked publications.
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 18 Nov 2023.