Overview

This trial is active, not recruiting.

Condition post operative pain
Treatments 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.
Sponsor Medical College of Wisconsin
Collaborator Children's Hospital and Health System Foundation, Wisconsin
Start date June 2005
End date December 2013
Trial size 300 participants
Trial identifier NCT00743730, CHW 05/02, HRRC 008-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
Parent and Nurse Controlled Analgesics with basal
pain and standard side effect management for pnca with basal method. PNCA with basal
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.
(Active Comparator)
Parent and Nurse Controlled Analgesics without basal
pain and standard side effect management with pnca without basal PNCA without basal
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.
(Active Comparator)
Intermittent opioid administered IV on an "as needed" basis
pain and standard side effect management with iv on an as needed basis method. morphine injection
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.

Primary Outcomes

Measure
Pain scores
time frame: every 1-4 hours while on study

Secondary Outcomes

Measure
Side effect profile (administration of medications to treat side effects)
time frame: Daily
Parent & Nurse satisfaction with the administration technique used for each subject
time frame: Nurses-each shift; parents, once at the end of study

Eligibility Criteria

Male or female participants from 4 years up to 18 years old.

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 -

Additional Information

Official title Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay
Principal investigator Michelle Czarnecki, MSN RN CPNP
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.