Trial Outcomes & Findings for Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery. (NCT NCT01094522)
NCT ID: NCT01094522
Last Updated: 2017-09-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
47 participants
Primary outcome timeframe
0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs
Results posted on
2017-09-18
Participant Flow
Total 47 subjects were enrolled. 7 were withdrawn prior to randomization. 40 were randomized.
Participant milestones
| Measure |
Methadone
One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
Morphine
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.
Baseline characteristics by cohort
| Measure |
Methadone
n=20 Participants
One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
Morphine
n=20 Participants
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1.00 years
n=5 Participants
|
1.37 years
n=7 Participants
|
1.19 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrsOutcome measures
| Measure |
Morphine
n=20 Participants
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
Morphine
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
|---|---|---|
|
Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide)
Morphine
|
27.55 ng/mL
Interval 0.317 to 348.0
|
—
|
|
Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide)
M3G
|
225 ng/mL
Interval 0.39 to 2630.0
|
—
|
|
Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide)
M6G
|
22.95 ng/mL
Interval 0.861 to 383.0
|
—
|
PRIMARY outcome
Timeframe: 0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrsOutcome measures
| Measure |
Morphine
n=20 Participants
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
Morphine
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
|---|---|---|
|
Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP)
Methadone
|
52.35 ng/mL
Interval 0.702 to 829.0
|
—
|
|
Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP)
EDDP
|
3.42 ng/mL
Interval 0.257 to 108.0
|
—
|
|
Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP)
EMDP
|
0.194 ng/mL
Interval 0.101 to 0.537
|
—
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Hourly FLACC score was calculated for 16 subjects in Methadone group and 19 subjects in morphine group
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
Outcome measures
| Measure |
Morphine
n=16 Participants
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
Morphine
n=19 Participants
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
|---|---|---|
|
•Pain Scores (FLACC) During the 24 Hours Study Period
|
1.375 units on a scale
Interval 0.0 to 3.375
|
1.917 units on a scale
Interval 0.0 to 4.792
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Morphine
n=20 Participants
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
Morphine
n=20 Participants
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
|---|---|---|
|
•Amount of Study Drug Administered During the 24-hour Dosing Period
|
8.56 mg
Interval 1.0 to 29.4
|
13.77 mg
Interval 1.7 to 88.7
|
Adverse Events
Methadone
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Morphine
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methadone
n=20 participants at risk
One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
Morphine
n=20 participants at risk
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
|---|---|---|
|
Infections and infestations
Culture negative sepsis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Surgical and medical procedures
Left vocal cord paralysis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Left pleural effusion
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema requiring re-intubation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure requiring re-intubation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Renal and urinary disorders
UTI
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Duodenal atresia requiring surgery
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Apnea requiring re-intubation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Other adverse events
| Measure |
Methadone
n=20 participants at risk
One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
Morphine
n=20 participants at risk
One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
|
|---|---|---|
|
Investigations
Self-extubation
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
|
Infections and infestations
Culture negative sepsis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema requiring re-intubation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Renal and urinary disorders
UTI
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Duodenal atresia requiring surgery
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Apnea requiring re-intubation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Additional Information
Dr. Gregory Hammer
Stanford University School of Medicine
Phone: 6507367359
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place