Trial Outcomes & Findings for Methadone vs Magnesium in Spinal Fusion (NCT NCT01795495)
NCT ID: NCT01795495
Last Updated: 2018-02-08
Results Overview
To prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Intra-operative and 24 hours post-operatively
Results posted on
2018-02-08
Participant Flow
Participant milestones
| Measure |
Remifentanil
This arm will receive remifentanil alone as is the current practice.
Remifentanil
|
Remifentanil Plus Methadone
This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.
Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia
|
Remifentanil Plus Magnesium
This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.
Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
21
|
|
Overall Study
COMPLETED
|
19
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Remifentanil
This arm will receive remifentanil alone as is the current practice.
Remifentanil
|
Remifentanil Plus Methadone
This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.
Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia
|
Remifentanil Plus Magnesium
This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.
Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Methadone vs Magnesium in Spinal Fusion
Baseline characteristics by cohort
| Measure |
Remifentanil
n=20 Participants
This arm will receive remifentanil alone as is the current practice.
Remifentanil
|
Remifentanil Plus Methadone
n=22 Participants
This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.
Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia
|
Remifentanil Plus Magnesium
n=21 Participants
This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.
Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.2 years
STANDARD_DEVIATION 1.4 • n=99 Participants
|
15.4 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
15.3 years
STANDARD_DEVIATION 1.9 • n=206 Participants
|
15.0 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
BMI (kg/m2)
|
21.6 kg/m^2
STANDARD_DEVIATION 4.3 • n=99 Participants
|
22.8 kg/m^2
STANDARD_DEVIATION 5.7 • n=107 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 5.6 • n=206 Participants
|
22.6 kg/m^2
STANDARD_DEVIATION 5.3 • n=7 Participants
|
PRIMARY outcome
Timeframe: Intra-operative and 24 hours post-operativelyTo prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively.
Outcome measures
| Measure |
Remifentanil
n=19 Participants
This arm will receive remifentanil alone as is the current practice.
Remifentanil
|
Remifentanil Plus Methadone
n=22 Participants
This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.
Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia
|
Remifentanil Plus Magnesium
n=19 Participants
This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.
Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).
|
|---|---|---|---|
|
Intra- and Post-operative Pain Relief
|
0.34 mg/kg
Standard Deviation 0.11
|
0.26 mg/kg
Standard Deviation 0.1
|
0.38 mg/kg
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Post-operatively to 24 hoursVAS pain score - 0 being no pain and 10 being worst pain.
Outcome measures
| Measure |
Remifentanil
n=19 Participants
This arm will receive remifentanil alone as is the current practice.
Remifentanil
|
Remifentanil Plus Methadone
n=22 Participants
This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.
Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia
|
Remifentanil Plus Magnesium
n=19 Participants
This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.
Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).
|
|---|---|---|---|
|
Post-operative Pain Scores
|
4.6 units on a scale
Standard Deviation 2.2
|
5.1 units on a scale
Standard Deviation 1.8
|
5.1 units on a scale
Standard Deviation 1.2
|
Adverse Events
Remifentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Remifentanil Plus Methadone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Remifentanil Plus Magnesium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place