Clinical trial NCT00743730: Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay
Official title: Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: developmental delay
cognitive impairment
pain control
post operative pain
opioid
pain assessment
Parent Nurse controlled Analgesic
patient controlled analgesic
children
pain
analgesic
safety
parent satisfaction
nurse satisfaction
Pediatric
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2008-08-29
Enrollment: 94
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. Parent/Nurse controlled Analgesia (PNCA) with a continuous intravenous (IV)infusion of pain medicine.
2. PNCA without continuous IV infusion of pain medicine.
3. 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale
timeFrame: First 24 hours on study
Secondary outcomes:
measure: Number of Patients Requiring Naloxone for Respiratory Depression
timeFrame: Daily, for up to 3 days
measure: Parent Satisfaction With the Administration Technique
timeFrame: parents, once at the end of study
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Childrens Hospital of Wisconsin
name: Michelle Czarnecki, MSN RN CPNP
role: PRINCIPAL_INVESTIGATOR
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