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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
94
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.
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale
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.
Time frame: First 24 hours on study
Number of Patients Requiring Naloxone for Respiratory Depression
Number of patients requiring naloxone for respiratory depression (our most important side effect)
Time frame: Daily, for up to 3 days
Parent Satisfaction With the Administration Technique
Parents were asked "Overall, how satisfied were you with the pain relief your child received after surgery?" Response options were: 1. Very Dissatisfied, 2. Dissatisfied, 3. Satisfied, 4. Very Satisfied. Responses were scored on a 1-4 scale, with Very Dissatisfied = 1; Dissatisfied = 2; Satisfied = 3; Very Satisfied = 4.
Time frame: parents, once at the end of study
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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.