PainMEPAIINCT01990573
Methadone in Pediatric Anesthesiology II
A study testing 0.3mg/kg IV methadone HCl and 0.4mg/kg IV methadon HCl in people with Pain, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg). Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Pain
- What is being tested?
- 0.3mg/kg IV methadone HCl and 0.4mg/kg IV methadon HCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2013to 30 Jun 2018
- Phase
- Interventional
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 11-18 years
- Undergoing general anesthesia and idiopathic posterior spinal surgery with anticipated postop inpatient stay of > 3 days
- Signed, written, informed consent from legal guardians and assent from patient
Who cannot join
- History of or known liver or kidney disease.
- Females who are pregnant or nursing.
- Children with developmental delay
- Children undergoing surgery for scoliosis of musculoskeletal origin
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Methadone in Pediatric Anesthesia II
Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).
Read the detailed description
Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care are not altered for study purposes. All patients are induced by propofol and muscle relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4 mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid) or methadone HCl (0.3 mg/kg ideal body weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. In the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. Patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.
- Conditions
- Pain
- Being tested
- 0.3mg/kg IV methadone HCl, 0.4mg/kg IV methadon HCl, control no methadone
- Keywords
- spinal surgery, Methadone
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3mg/kg IV methadone HClDrug
Also called methadone HCl, dolophine
Group I will receive 0.3mg/kg IV methadone HCl
0.4mg/kg IV methadon HClDrug
Also called methadone HCl, dolophine
Group II will receive 0.4mg/kg IV methadone HCl.
control no methadoneOther
The control group will not receive methadone.
| Study group | Role | What they receive |
|---|---|---|
| methadone HCl 0.3 mg/kg | Experimental | 0.3mg/kg IV methadone HCl Receives: Drug: 0.3mg/kg IV methadone HCl |
| methadone HCl 0.4 mg/kg | Experimental | 0.4mg/kg IV methadon HCl Receives: Drug: 0.4mg/kg IV methadon HCl |
| control group | Active comparator | control no methadone, standard of care opioids. Receives: Other: control no methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption (Morphine Equivalent)
Measure of overall morphine consumption
Measured: 6 days
Pain Scores
Assessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated .
Measured: 6 days
Secondary outcomes (1)
Cmax of R and S Methadone
Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study start10 Apr 2013
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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 PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anshuman Sharma, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990573
- Sponsor's protocol ID
- 201302099
- Acronym
- MEPAII
- Status last verified
- Jan 2020
- First submitted
- 7 Nov 2013
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone in Pediatric Anesthesia II
- ClinicalTrials.gov ID
- NCT01990573
- Acronym / sponsor ID
- MEPAII / 201302099
- Conditions
- Pain
- Keywords
- spinal surgery, Methadone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 10 Apr 2013 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Posted 28 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).
Detailed description
Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care are not altered for study purposes. All patients are induced by propofol and muscle relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4 mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid) or methadone HCl (0.3 mg/kg ideal body weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. In the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. Patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| methadone HCl 0.3 mg/kg | Experimental | Drug: 0.3mg/kg IV methadone HCl0.3mg/kg IV methadone HCl |
| methadone HCl 0.4 mg/kg | Experimental | Drug: 0.4mg/kg IV methadon HCl0.4mg/kg IV methadon HCl |
| control group | Active comparator | Other: control no methadonecontrol no methadone, standard of care opioids. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 11-18 years
- Undergoing general anesthesia and idiopathic posterior spinal surgery with anticipated postop inpatient stay of > 3 days
- Signed, written, informed consent from legal guardians and assent from patient
Key exclusion criteria (4 listed)
- History of or known liver or kidney disease.
- Females who are pregnant or nursing.
- Children with developmental delay
- Children undergoing surgery for scoliosis of musculoskeletal origin
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 |
|---|---|---|
| 0.3mg/kg IV methadone HClAlso: methadone HCl, dolophineGroup I will receive 0.3mg/kg IV methadone HCl | Drug | methadone HCl 0.3 mg/kg |
| 0.4mg/kg IV methadon HClAlso: methadone HCl, dolophineGroup II will receive 0.4mg/kg IV methadone HCl. | Drug | methadone HCl 0.4 mg/kg |
| control no methadoneThe control group will not receive methadone. | Other | control group |
Primary outcome
Total Opioid Consumption (Morphine Equivalent)
Time frame: 6 days
Measure of overall morphine consumption
Pain Scores
Time frame: 6 days
Assessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated .
1 secondary outcome
Cmax of R and S Methadone
Time frame: 96 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anshuman Sharma, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.3mg/kg IV methadone HCl and 0.4mg/kg IV methadon HCl in people with Pain, run by Washington University School of Medicine 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 3 inclusion and 4 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 28 Jan 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 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 Opioid Consumption (Morphine Equivalent) (time frame: 6 days). The study lists 2 primary outcomes in all. 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 28 Jan 2020.