Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay

Post Operative Pain Clinical Trial

— PNCA  

Official title:

Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743730
• Other study ID #: CHW 05/02, HRRC 008-05
• Status: Completed
• Phase: N/A
• Start date: June 2005
• Est. completion date: February 2010

Study information

• Verified date: August 2019
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (18)

Doyle E, Harper I, Morton NS. Patient-controlled analgesia with low dose background infusions after lower abdominal surgery in children. Br J Anaesth. 1993 Dec;71(6):818-22. — View Citation

Doyle E, Robinson D, Morton NS. Comparison of patient-controlled analgesia with and without a background infusion after lower abdominal surgery in children. Br J Anaesth. 1993 Nov;71(5):670-3. — View Citation

Foster RL, Varni JW. Measuring the quality of children's postoperative pain management: initial validation of the child/parent Total Quality Pain Management (TQPM) instruments. J Pain Symptom Manage. 2002 Mar;23(3):201-10. — View Citation

Gaukroger PB, Tomkins DP, van der Walt JH. Patient-controlled analgesia in children. Anaesth Intensive Care. 1989 Aug;17(3):264-8. — View Citation

Gureno MA, Reisinger CL. Patient controlled analgesia for the young pediatric patient. Pediatr Nurs. 1991 May-Jun;17(3):251-4. — View Citation

Kotzer AM, Foster R. Children's use of PCA following spinal fusion. Orthop Nurs. 2000 Sep-Oct;19(5):19-27; quiz 28-30. — View Citation

Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Lauer A, Munro H, Farley F. Pain management in children with and without cognitive impairment following spine fusion surgery. Paediatr Anaesth. 2001 Jul;11(4):453-8. — View Citation

McGrath PJ, Rosmus C, Canfield C, Campbell MA, Hennigar A. Behaviours caregivers use to determine pain in non-verbal, cognitively impaired individuals. Dev Med Child Neurol. 1998 May;40(5):340-3. — View Citation

McNeely JK, Trentadue NC. Comparison of patient-controlled analgesia with and without nighttime morphine infusion following lower extremity surgery in children. J Pain Symptom Manage. 1997 May;13(5):268-73. — View Citation

Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7. — View Citation

Miaskowski C, Crews J, Ready LB, Paul SM, Ginsberg B. Anesthesia-based pain services improve the quality of postoperative pain management. Pain. 1999 Mar;80(1-2):23-9. — View Citation

Oberlander TF, Gilbert CA, Chambers CT, O'Donnell ME, Craig KD. Biobehavioral responses to acute pain in adolescents with a significant neurologic impairment. Clin J Pain. 1999 Sep;15(3):201-9. — View Citation

Pellino TA, Ward SE. Perceived control mediates the relationship between pain severity and patient satisfaction. J Pain Symptom Manage. 1998 Feb;15(2):110-6. — View Citation

Peters JW, Bandell Hoekstra IE, Huijer Abu-Saad H, Bouwmeester J, Meursing AE, Tibboel D. Patient controlled analgesia in children and adolescents: a randomized controlled trial. Paediatr Anaesth. 1999;9(3):235-41. — View Citation

Rodgers BM, Webb CJ, Stergios D, Newman BM. Patient-controlled analgesia in pediatric surgery. J Pediatr Surg. 1988 Mar;23(3):259-62. — View Citation

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.

Voepel-Lewis T, Merkel S, Tait AR, Trzcinka A, Malviya S. The reliability and validity of the Face, Legs, Activity, Cry, Consolability observational tool as a measure of pain in children with cognitive impairment. Anesth Analg. 2002 Nov;95(5):1224-9, table of contents. — View Citation

Yildiz K, Tercan E, Dogru K, Ozkan U, Boyaci A. Comparison of patient-controlled analgesia with and without a background infusion after appendicectomy in children. Paediatr Anaesth. 2003 Jun;13(5):427-31. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale	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.	First 24 hours on study
Secondary	Number of Patients Requiring Naloxone for Respiratory Depression	Number of patients requiring naloxone for respiratory depression (our most important side effect)	Daily, for up to 3 days
Secondary	Parent Satisfaction With the Administration Technique	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.	parents, once at the end of study