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

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Michelle Czarnecki, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00743730
First received: June 12, 2008
Last updated: September 26, 2016
Last verified: September 2016
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale [ Time Frame: First 24 hours on study ] [ Designated as safety issue: No ]
    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:
  • Side Effect Profile (Administration of Medications to Treat Side Effects) [ Time Frame: Daily, for up to 3 months ] [ Designated as safety issue: Yes ]
  • Parent Satisfaction With the Administration Technique [ Time Frame: parents, once at the end of study ] [ Designated as safety issue: No ]
    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.


Enrollment: 94
Study Start Date: June 2005
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
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.

Other Name: PNCA with basal
Active Comparator: II
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.

Other Name: PNCA without basal
Active Comparator: III
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.

Other Names:
  • morphine injection
  • pain medication administered by IV as needed

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743730

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Michelle Czarnecki, MSN RN CPNP Childrens Hospital of Wisconsin
  More Information

Publications:
Rusy, L. M., Olsen, D. J., & Farber, N. E. (1997). Successful use of patient-controlled analgesia in pediatric patients 2 and 3 years old: Two case reports. Am J Anesthesiol, 14(4), 212-214.

Responsible Party: Michelle Czarnecki, Advanced Practice Nurse, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00743730     History of Changes
Other Study ID Numbers: CHW 05/02, HRRC 008-05 
Study First Received: June 12, 2008
Results First Received: November 4, 2015
Last Updated: September 26, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016