Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay (PNCA)

Medical College of Wisconsin

Status: Completed

Conditions: Post Operative Pain

Treatments: 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.; Other: Pain and standard side effect management for PNCA with basal method.

Study type: Interventional

Funder types: Other

Identifiers

NCT00743730

CHW 05/02, HRRC 008-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

I

Active Comparator group

Description:

Parent and Nurse Controlled Analgesics with basal

Treatment:

Other: Pain and standard side effect management for PNCA with basal method.

II

Active Comparator group

Description:

Parent and Nurse Controlled Analgesics without basal

Treatment:

Other: Pain and standard side effect management with PNCA without basal

III

Active Comparator group

Description:

Intermittent opioid administered IV on an "as needed" basis

Treatment:

Other: Pain and standard side effect management with IV on an as needed basis method.