N/A
Completed N=36
Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
Abdominal Surgery · thoracic surgery
Source: ClinicalTrials.gov NCT01823497 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Morphine Consumption — 0.014; 0.036 mg/kg/hr
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morphine Consumption |
0.014; 0.036 | — |
| SECONDARY Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale |
1.25; 1.67; 1.79; 1.083; 2.17; 1.83 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01823497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.