Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay
NCT ID: NCT00743730
Last Updated: 2019-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2005-06-30
2010-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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I
Parent and Nurse Controlled Analgesics with basal
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
Parent and Nurse Controlled Analgesics without basal
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
Intermittent opioid administered IV on an "as needed" basis
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
* 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 -
4 Years
18 Years
ALL
No
Sponsors
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Children's Hospital and Health System Foundation, Wisconsin
OTHER
Medical College of Wisconsin
OTHER
Responsible Party
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Michelle Czarnecki
Advanced Practice Nurse
Principal Investigators
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Michelle Czarnecki, MSN RN CPNP
Role: PRINCIPAL_INVESTIGATOR
Childrens Hospital of Wisconsin
Locations
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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. doi: 10.1093/bja/71.6.818.
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. doi: 10.1093/bja/71.5.670.
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. doi: 10.1016/s0885-3924(01)00411-0.
Gaukroger PB, Tomkins DP, van der Walt JH. Patient-controlled analgesia in children. Anaesth Intensive Care. 1989 Aug;17(3):264-8. doi: 10.1177/0310057X8901700304.
Gureno MA, Reisinger CL. Patient controlled analgesia for the young pediatric patient. Pediatr Nurs. 1991 May-Jun;17(3):251-4.
Kotzer AM, Foster R. Children's use of PCA following spinal fusion. Orthop Nurs. 2000 Sep-Oct;19(5):19-27; quiz 28-30. doi: 10.1097/00006416-200019050-00005.
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. doi: 10.1046/j.1460-9592.2001.00686.x.
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.
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. doi: 10.1016/s0885-3924(96)00324-7.
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.
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. doi: 10.1016/s0304-3959(98)00192-4.
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. doi: 10.1097/00002508-199909000-00007.
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.
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. doi: 10.1046/j.1460-9592.1999.00358.x.
Rodgers BM, Webb CJ, Stergios D, Newman BM. Patient-controlled analgesia in pediatric surgery. J Pediatr Surg. 1988 Mar;23(3):259-62. doi: 10.1016/s0022-3468(88)80735-8.
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. doi: 10.1097/00000539-200211000-00020.
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. doi: 10.1046/j.1460-9592.2003.01061.x.
Czarnecki ML, Hainsworth K, Simpson PM, Arca MJ, Uhing MR, Zhang L, Grippe A, Varadarajan J, Rusy LM, Firary M, Weisman SJ. A Pilot Randomized Controlled Trial of Outcomes Associated with Parent-Nurse Controlled Analgesia vs. Continuous Opioid Infusion in the Neonatal Intensive Care Unit. Pain Manag Nurs. 2020 Feb;21(1):72-80. doi: 10.1016/j.pmn.2019.08.002. Epub 2019 Sep 4.
Czarnecki ML, Hainsworth KR, Simpson PM, Weisman SJ. Parent/Nurse-Controlled Analgesia Compared with Intravenous PRN Opioids for Postsurgical Pain Management in Children with Developmental Delay: A Randomized Controlled Trial. Pain Med. 2018 Apr 1;19(4):742-752. doi: 10.1093/pm/pnx257.
Other Identifiers
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CHW 05/02, HRRC 008-05
Identifier Type: -
Identifier Source: org_study_id
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