Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): Pain and standard side effect management for PNCA with basal method.; Pain and standard side effect management with PNCA without basal; Pain and standard side effect management with IV on an as needed basis method.
Intervention type(s): Other; Other; Other
Intervention description(s): Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure.; Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure.; Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol.
Other intervention name(s): PNCA with basal; PNCA without basal; morphine injection; pain medication administered by IV as needed
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
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