Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay

Study Overview
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Brief Summary
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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
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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.

Official Title
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Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay

Conditions
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Post Operative Pain

Intervention / Treatment
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* Other: Pain and standard side effect management for PNCA with basal method.
* Other: Pain and standard side effect management with PNCA without basal
* Other: Pain and standard side effect management with IV on an as needed basis method.


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Parent and Nurse Controlled Analgesics with basal | Other: Pain and standard side effect management for PNCA with basal method.<br>* 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.<br>* Other names: PNCA with basal;|
| Active Comparator: II<br>Parent and Nurse Controlled Analgesics without basal | Other: Pain and standard side effect management with PNCA without basal<br>* 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.<br>* Other names: PNCA without basal;|
| Active Comparator: III<br>Intermittent opioid administered IV on an as needed basis | Other: Pain and standard side effect management with IV on an as needed basis method.<br>* 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.<br>* Other names: pain medication administered by IV as needed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | First 24 hours on study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Requiring Naloxone for Respiratory Depression | Number of patients requiring naloxone for respiratory depression (our most important side effect) | 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. | parents, once at the end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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