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| Sponsors and Collaborators: |
Medical College of Wisconsin Childrens Research Institute Mayday Fund |
|---|---|
| Information provided by: | Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00743730 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Post Operative Pain |
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. |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay |
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Active Comparator
Parent and Nurse Controlled Analgesics with basal
|
Other: Pain and standard side effect management for PNCA with basal method.
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. |
|
II: Active Comparator
Parent and Nurse Controlled Analgesics without basal
|
Other: Pain and standard side effect management with 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. |
|
III: Active Comparator
Intermittent opioid administered IV on an "as needed" basis
|
Other: Pain and standard side effect management with IV on an as needed basis method.
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. |
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:
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.
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michelle Czarnecki, MSN,RN,CPNP | 414-266-3133 | Mczarnecki@chw.org |
| Contact: Steven Weisman, MD | 414-266-3133 | sweisman@chw.org |
| United States, Wisconsin | |
| Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Sharon L. Eisch, RN 414-266-3133 seisch@chw.org | |
| Contact: Michelle Czarnecki, APN 414-266-3133 mczarnecki@chw.org | |
| Principal Investigator: Michelle Czarnecki, MSN,CPNP,APN | |
| Principal Investigator: | Michelle Czarnecki, MSN RN CPNP | Childrens Hospital of Wisconsin |
More Information
| Responsible Party: | Children's Hospital of Wisconsin ( Michellle Czarnecki, MSN, RN, CPNP / Advanced Practice Nurse ) |
| Study ID Numbers: | CHW 05/02, HRRC 008-05 |
| Study First Received: | June 12, 2008 |
| Last Updated: | October 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00743730 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
|
Morphine Signs and Symptoms Postoperative Complications Pain Pain, Postoperative |
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Pathologic Processes |
