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

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

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.

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: Parent/Nurse controlled Analgesia (PNCA) with a continuous intravenous (IV)infusion of pain medicine. PNCA without continuous IV infusion of pain medicine. 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.

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

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.

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.

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.

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.

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.

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 -

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.