Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale
Overview
Brief Summary
The purpose of this study is to compare, the safety, efficacy and level of parent and nurse satisfaction with three methods of opioid administration post-operatively in children (4-18 years of age) with developmental delay.
Detailed Description
Children with developmental delay are at higher risk for inadequate pain assessment and management. Patient controlled analgesia (PCA) allows patients to administer opioids by pushing a PCA button when needed. This eliminates the delay of waiting for a nurse to obtain and administer pain medication. PCA has been shown to be safe, effective, and superior to intramuscular, intermittent opioid dosing for pain management in children. Often, children with developmental delays cannot operate a PCA independently, can not self report their pain and are often given pain medication "as needed" through an IV. Parent/Nurse Controlled Analgesia (PNCA) allows parents and nurses to push the PCA button for patients who are not able to do so themselves. This way of giving pain medicine has not been thoroughly studied. Some healthcare professionals use PNCA for these children, others do not. This study is being done to compare PNCA & intermittent opioid administration. Participants will be randomized into one of the three study groups:
- Parent/Nurse controlled Analgesia (PNCA) with a continuous intravenous (IV)infusion of pain medicine.
- PNCA without continuous IV infusion of pain medicine.
- Pain medicine given through IV administered on an "as needed" basis(PRN) by the nurse.
The Acute Pain Service will follow all three groups of patients throughout the study. This team specializes in the management of children's pain. Pain team is also available 24 hours a day, 7 days a week. The study will continue until child can tolerate pain medication in his/her stomach.
Data will be collected regarding safety, efficacy, parent & Nurse satisfaction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children with developmental delay between 4 and 18 years of age who are unable to operate PCA due to developmental delay.
- •Children scheduled for surgery anticipated to require \>24hour stay with anticipation of IV narcotics will be required.
- •Children whose parents are able to verbalize an understanding of PNCA.
- •Parents with fluency in english(both speaking and writing).
Exclusion Criteria
- •Patients who do not meet inclusion criteria
- •Patients whose parents do not give informed consent
- •patients allergic to both morphine and hydromorphone
- •patients with severe physiologically altering obstructive sleep apnea
- •Patients who are or are expected to remain on a ventilator
- •Patients receiving an epidural -
Outcomes
Primary Outcomes
Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale
Time Frame: First 24 hours on study
Pain is measured with the Face, Legs, Activity, Cry, Consolability scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The median pain score over the first shift (24 hours) is reported.
Secondary Outcomes
- Number of Patients Requiring Naloxone for Respiratory Depression(Daily, for up to 3 days)
- Parent Satisfaction With the Administration Technique(parents, once at the end of study)
Investigators
Michelle Czarnecki
Advanced Practice Nurse
Medical College of Wisconsin