Trial Outcomes & Findings for Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit (NCT NCT01823497)
NCT ID: NCT01823497
Last Updated: 2020-09-02
Results Overview
The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
5 days post surgery
Results posted on
2020-09-02
Participant Flow
Participant milestones
| Measure |
Parent/Nurse Controlled Analgesia
Parent/Nurse Controlled Analgesia will be the method of morphine delivery.
Morphine: Morphine will be used to control pain post-surgery.
|
Continuous Opioid Infusion
Continuous Opioid Infusion will be the method used to deliver morphine to group 2
Morphine: Morphine will be used to control pain post-surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
16
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Parent/Nurse Controlled Analgesia
n=16 Participants
Parent/Nurse Controlled Analgesia will be the method of morphine delivery.
Morphine: Morphine will be used to control pain post-surgery.
|
Continuous Opioid Infusion
n=9 Participants
Continuous Opioid Infusion will be the method used to deliver morphine to group 2
Morphine: Morphine will be used to control pain post-surgery.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4 days
n=5 Participants
|
2 days
n=7 Participants
|
4 days
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
9 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 days post surgeryThe investigators will measure amount of morphine consumed post-surgery in mg/kg/hour
Outcome measures
| Measure |
Parent/Nurse Controlled Analgesia
n=16 Participants
Parent/Nurse Controlled Analgesia will be the method of morphine delivery.
Morphine: Morphine will be used to control pain post-surgery.
|
Continuous Opioid Infusion
n=9 Participants
Continuous Opioid Infusion will be the method used to deliver morphine to group 2
Morphine: Morphine will be used to control pain post-surgery.
|
|---|---|---|
|
Morphine Consumption
|
0.014 mg/kg/hr
Interval 0.013 to 0.017
|
0.036 mg/kg/hr
Interval 0.036 to 0.04
|
SECONDARY outcome
Timeframe: 4 days post surgeryThe investigators will report the average pain score per POD, for 4 days (PODs 0,1,2,3). Higher scores mean worse outcome. Good pain control will be defined as pain less than 4 on a 0-10 scale. Pain is scored by observers on a minimum of 0 (no pain) to a maximum of 10 (worst pain) on this scale. The median and inter-quartile range of the average pain score per post-operative day is reported. The timeframe includes the post-operative day (POD 0), and 3 days post-surgery (POD 1-3), for a total of 4 post-operative days.
Outcome measures
| Measure |
Parent/Nurse Controlled Analgesia
n=16 Participants
Parent/Nurse Controlled Analgesia will be the method of morphine delivery.
Morphine: Morphine will be used to control pain post-surgery.
|
Continuous Opioid Infusion
n=9 Participants
Continuous Opioid Infusion will be the method used to deliver morphine to group 2
Morphine: Morphine will be used to control pain post-surgery.
|
|---|---|---|
|
Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale
Post-operative Day 1
|
1.79 units on a scale
Interval 1.37 to 2.55
|
1.083 units on a scale
Interval 0.0 to 3.18
|
|
Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale
Post-operative Day 3
|
1.00 units on a scale
Interval 0.0 to 2.44
|
1.25 units on a scale
Interval 0.31 to 2.45
|
|
Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale
Post-operative Day 0
|
1.25 units on a scale
Interval 0.43 to 2.81
|
1.67 units on a scale
Interval 0.0 to 4.42
|
|
Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale
Post-operative Day 2
|
2.17 units on a scale
Interval 0.31 to 2.36
|
1.83 units on a scale
Interval 0.58 to 3.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 3 days after morphine is discontinuedMethadone will serve as a surrogate for tolerance and will be monitored up to 3 days after the morphine has been discontinued.
Outcome measures
Outcome data not reported
Adverse Events
Parent/Nurse Controlled Analgesia
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Continuous Opioid Infusion
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Parent/Nurse Controlled Analgesia
n=16 participants at risk
Parent/Nurse Controlled Analgesia will be the method of morphine delivery.
Morphine: Morphine will be used to control pain post-surgery.
|
Continuous Opioid Infusion
n=9 participants at risk
Continuous Opioid Infusion will be the method used to deliver morphine to group 2
Morphine: Morphine will be used to control pain post-surgery.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Naloxone, reintubation, or methadone
|
0.00%
0/16 • Adverse events were collected up to 3 post-operative days
The intervention involved in this study would not be associated with all-cause mortality
|
0.00%
0/9 • Adverse events were collected up to 3 post-operative days
The intervention involved in this study would not be associated with all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Sedation
|
43.8%
7/16 • Number of events 7 • Adverse events were collected up to 3 post-operative days
The intervention involved in this study would not be associated with all-cause mortality
|
55.6%
5/9 • Number of events 5 • Adverse events were collected up to 3 post-operative days
The intervention involved in this study would not be associated with all-cause mortality
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place