This trial is active, not recruiting.

Conditions abdominal surgery, thoracic surgery
Treatment morphine
Sponsor Medical College of Wisconsin
Collaborator Children's Hospital and Health System Foundation, Wisconsin
Start date April 2013
End date December 2016
Trial size 60 participants
Trial identifier NCT01823497, FP4155


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Parent/Nurse Controlled Analgesia will be the method of morphine delivery.
Morphine will be used to control pain post-surgery.
(Active Comparator)
Continuous Opioid Infusion will be the method used to deliver morphine to group 2
Morphine will be used to control pain post-surgery.

Primary Outcomes

Morphine Consumption
time frame: 5 days post surgery

Secondary Outcomes

Pain Control
time frame: 5 days post surgery

Eligibility Criteria

Male or female participants up to 70 days old.

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

Additional Information

Official title Parent/Nurse Controlled Analgesia for Post-Operative Pain Management in Neonates: A Preliminary Randomized Controlled Trial
Principal investigator Keri R Hainsworth, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.