Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit

Thoracic Surgery Clinical Trial

— PNCA  

Official title:

Parent/Nurse Controlled Analgesia for Post-Operative Pain Management in Neonates: A Preliminary Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823497
• Other study ID #: FP4155
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: March 2019

Study information

• Verified date: August 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Days

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery
• Thoracic Surgery

Intervention

Drug:
• Morphine
Morphine will be used to control pain post-surgery.

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Methadone Use	Methadone will serve as a surrogate for tolerance and will be monitored up to 3 days after the morphine has been discontinued.	up to 3 days after morphine is discontinued
Primary	Morphine Consumption	The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour	5 days post surgery
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.	4 days post surgery