Abdominal Surgery, Thoracic Surgery
Conditions
Keywords
Neonatal Intensive Care Unit, neonate, pain, morphine, Parent/Nurse Controlled Analgesia
Brief summary
The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled Analgesia pump will receive less morphine and experience fewer side effects than neonates receiving morphine via continuous opioid infusion.
Interventions
DRUGMorphine
Morphine will be used to control pain post-surgery.
Sponsors
Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 70 Days
Healthy volunteers
No
Inclusion criteria
* Surgery Location: * Abdominal or Thoracic * First surgery only Age: * Born ≥ 34-44 weeks post-menstrual age * Weight: Weight at birth or current weight ≥2 kg Intubated or extubated Prior opioid exposure: * \< 2 days of continuous exposure * if history of \> 2 day continuous exposure, must be off continuous drip for a week * Intermittent exposure ≤ 2 days prior to surgery Neonates exposed to chronic opioids in utero \*In utero exposure to Selective Seretonin Reuptake Inhibitors and illicit drugs will be screened for and annotated. At least 1 parent is English-speaking
Exclusion criteria
* Surgery Type: * Cardiac, Patent Ductus Arteriosus Ligation; Omphalocele (if intubated pre-operatively) Diagnoses: • Necrotizing Enterocolitis; Diaphragmatic hernia (unless thoracoscopically repaired); Chemically or physiologically paralyzed Receiving vasopressors Receiving acetaminophen or a benzodiazepine (lorazepam or midazolam) ≤ 24 h before surgery Patients with any of the following: Epidural; Oscillating ventilator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Consumption | 5 days post surgery | The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | 4 days post surgery | The 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Methadone Use | up to 3 days after morphine is discontinued | Methadone will serve as a surrogate for tolerance and will be monitored up to 3 days after the morphine has been discontinued. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 9 |
| Total | 25 |
Baseline characteristics
| Characteristic | Parent/Nurse Controlled Analgesia | Continuous Opioid Infusion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 9 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4 days | 2 days | 4 days |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 9 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 2 Participants | 16 Participants |
| Region of Enrollment United States | 16 participants | 9 participants | 25 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 9 |
| other Total, other adverse events | 7 / 16 | 5 / 9 |
| serious Total, serious adverse events | 0 / 16 | 0 / 9 |
Outcome results
Primary
Morphine Consumption
The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour
Time frame: 5 days post surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Parent/Nurse Controlled Analgesia | Morphine Consumption | 0.014 mg/kg/hr |
| Continuous Opioid Infusion | Morphine Consumption | 0.036 mg/kg/hr |
Secondary
Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale
The 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.
Time frame: 4 days post surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Parent/Nurse Controlled Analgesia | Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | Post-operative Day 0 | 1.25 units on a scale |
| Parent/Nurse Controlled Analgesia | Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | Post-operative Day 1 | 1.79 units on a scale |
| Parent/Nurse Controlled Analgesia | Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | Post-operative Day 2 | 2.17 units on a scale |
| Parent/Nurse Controlled Analgesia | Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | Post-operative Day 3 | 1.00 units on a scale |
| Continuous Opioid Infusion | Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | Post-operative Day 3 | 1.25 units on a scale |
| Continuous Opioid Infusion | Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | Post-operative Day 0 | 1.67 units on a scale |
| Continuous Opioid Infusion | Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | Post-operative Day 2 | 1.83 units on a scale |
| Continuous Opioid Infusion | Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | Post-operative Day 1 | 1.083 units on a scale |
Other Pre-specified
Methadone Use
Methadone will serve as a surrogate for tolerance and will be monitored up to 3 days after the morphine has been discontinued.
Time frame: up to 3 days after morphine is discontinued