Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay

Not Applicable

Completed

Conditions: Post Operative Pain

Interventions: 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.

Registration Number: NCT00743730

Lead Sponsor: Medical College of Wisconsin

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 94

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 -

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Pain and standard side effect management for PNCA with basal method.	Parent and Nurse Controlled Analgesics with basal
II	Pain and standard side effect management with PNCA without basal	Parent and Nurse Controlled Analgesics without basal
III	Pain and standard side effect management with IV on an as needed basis method.	Intermittent opioid administered IV on an "as needed" basis

Primary Outcome Measures

Name	Time	Method
Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale	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 Outcome Measures

Name	Time	Method
Number of Patients Requiring Naloxone for Respiratory Depression	Daily, for up to 3 days	Number of patients requiring naloxone for respiratory depression (our most important side effect)
Parent Satisfaction With the Administration Technique	parents, once at the end of study	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.