Trial · NCT01094522
Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.
NCT01094522, Phase 1, Phase 2, Completed, Stanford University; results first posted 2017-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery. Trials, record NCT01094522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01094522
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.
- NCT number
- NCT01094522
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Pain
- Interventions
- Methadone, Morphine
- First posted
- 2010-03-29
- Last updated
- 2017-09-18
- Results first posted
- 2017-08-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide) | 0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs | |
| Primary | Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP) | 0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs | |
| Secondary | •Pain Scores (FLACC) During the 24 Hours Study Period | 24 hours | Average of hourly FLACC score for each subject over 24 hours was calculated, followed by median and full range for total subjects in each arm. FLACC (Face, Leg, Activity, Cry, Consolability) score ranges from 0-10 with 0 representing no pain |
| Secondary | •Amount of Study Drug Administered During the 24-hour Dosing Period | 24 hours |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide) | 0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs | ng/mL | MEDIAN | |
| SECONDARY | •Pain Scores (FLACC) During the 24 Hours Study Period | 24 hours | Hourly FLACC score was calculated for 16 subjects in Methadone group and 19 subjects in morphine group | units on a scale | MEDIAN |
| SECONDARY | •Amount of Study Drug Administered During the 24-hour Dosing Period | 24 hours | mg | MEAN | |
| PRIMARY | Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP) | 0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs | ng/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide) | Morphine | Morphine | 27.55 | Full Range 0.317 to 348 | ng/mL |
| Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide) | Morphine | M3G | 225 | Full Range 0.39 to 2630 | ng/mL |
| Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide) | Morphine | M6G | 22.95 | Full Range 0.861 to 383 | ng/mL |
| •Pain Scores (FLACC) During the 24 Hours Study Period | Methadone | 1.375 | Full Range 0 to 3.375 | units on a scale | |
| •Pain Scores (FLACC) During the 24 Hours Study Period | Morphine | 1.917 | Full Range 0 to 4.792 | units on a scale | |
| •Amount of Study Drug Administered During the 24-hour Dosing Period | Methadone | 8.56 | Full Range 1 to 29.4 | mg | |
| •Amount of Study Drug Administered During the 24-hour Dosing Period | Morphine | 13.77 | Full Range 1.7 to 88.7 | mg | |
| Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP) | Methadone | Methadone | 52.35 | Full Range 0.702 to 829 | ng/mL |
| Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP) | Methadone | EDDP | 3.42 | Full Range 0.257 to 108 | ng/mL |
| Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP) | Methadone | EMDP | 0.194 | Full Range 0.101 to 0.537 | ng/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methadone | 20 | |
| Overall Study | STARTED | Morphine | 20 | |
| Overall Study | COMPLETED | Methadone | 20 | |
| Overall Study | COMPLETED | Morphine | 20 | |
| Overall Study | NOT COMPLETED | Methadone | 0 | |
| Overall Study | NOT COMPLETED | Morphine | 0 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Self-extubation | Investigations | Methadone | 0 | 20 | 0 |
| other | Self-extubation | Investigations | Morphine | 2 | 20 | 2 |
| other | Culture negative sepsis | Infections and infestations | Methadone | 1 | 20 | 1 |
| other | Culture negative sepsis | Infections and infestations | Morphine | 0 | 20 | 0 |
| other | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Methadone | 0 | 20 | 0 |
| other | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Morphine | 1 | 20 | 1 |
| other | Pulmonary edema requiring re-intubation | Respiratory, thoracic and mediastinal disorders | Methadone | 1 | 20 | 1 |
| other | Pulmonary edema requiring re-intubation | Respiratory, thoracic and mediastinal disorders | Morphine | 0 | 20 | 0 |
| other | Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Methadone | 1 | 20 | 1 |
| other | Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Morphine | 0 | 20 | 0 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methadone | ||
| Total, all-cause mortality | Morphine | ||
| Total, other adverse events | Methadone | 5 | 20 |
| Total, other adverse events | Morphine | 4 | 20 |
| Total, serious adverse events | Methadone | 5 | 20 |
| Total, serious adverse events | Morphine | 3 | 20 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Methadone vs Morphine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01094522
GET https://conductscience.org/api/trials/v1/NCT01094522/events?page=2