None listed
Conditions
Brief summary
A model of neonatal nurse-controlled analgesia (NNCA) to manage neonatal surgical pain has been developed. This model was informed through the literature, the results of a systematic review, a survey of current Australasian neonatal pain practices and an expert panel of neonatal clinicians/researchers with knowledge/expertise of pain assessment and management practice across Australia and New Zealand. The final model of this NNCA will be tested in the Cardiac/surgical neonatal intensive care unit (C/S:NCCU) of the Mater Mothers’ Hospital South Brisbane. This pilot trial will be a randomised controlled trial to test the feasibility of study methodology. Infants will be randomised into either the control arm and receive current standard postoperative pain management or the intervention arm in which infants will receive postoperative pain management as per the model of NNCA.
Interventions
Path A (less than12hrs post-operative) Infants will commence on pathway A on return from theatre. • Depending on if the infant is already receiving an opioid infusion prior to surgical intervention and/ or amount of analgesia administered intra-operatively, consideration of a loading dose of morphine will occur on return to the neonatal unit following a medical review. • Nursing staff will administer a bolus of 25micrograms/kg of morphine every 15minutes during first hour post-operatively to a maximum of 75mircograms/kg to achieve a modified pain assessment tool (MPAT) score equal to or less than 4. If three boluses are needed, increase the infusion rate by 5micrograms/kg/hr. • IV Paracetamol 7.5mg/kg to be commenced within 2hrs of commencing on Pathway A if not administered to infant in the previous 6hrs. • Reassess infant MPAT pain score in 60mins. • If achieving a MPAT score less than or equal to 4, the infant will use LOW pathway. • If MPAT scores are between 5 and 9, the infant will use MOD pathway. • If MPAT scores are greater than or equal to 10, the infant will use SEV pathway. • If after 12hours, infant achieving MOD scores or lower, transition to Path B. If scores are in the SEV range, continue on Path A until MOD scores are achieved or Neonatal Nurse Controlled Analgesia (NNCA) is suspended as per designated pathway. LOW pathway 1. Continue current rate of morphine infusion. 2. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly skin to therapy (as appropriate with consideration of type of surgery and time elapsed. 3. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs. 4. Reassess pain scores using MPAT every 60mins. 5. One cycle is steps 1-4. 6. If MPAT scores remains equal to or less than 4, continue management as per steps 1-4. MOD pathway 1. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly skin to therapy (as appropriate with consideration of type of surgery and time elapsed. 2. Explore other potential sources of pain or discomfort. 3. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs. 4. Reassess MPAT scores every 30-60mins. 5. One cycle constitutes steps 1-4. 6. If MPAT score remains in this range after 30-60mins, complete steps 1-4 again 7. If after completing two cycles through this pathway a medical review is required. 8. Increase morphine infusion by 5microgs/kg/hr and reassess in 30-60mins. (Morphine must not exceed 15microgs/kg/hr for non-intubated infants and 20microgs/kg/hr for intubated infants on the MOD pathway. 9. If MPAT score remains in the MOD range, continue on this pathway, progressing through each cycle. 10. If infant requires morphine > 20microgs/kg/hr, infant to escalate to the SEV pathway. 11. If morphine does not exceed defined limits for the MOD pathway, transition to Path B after 12hours postoperative. SEV pathway 1. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly skin to therapy (as appropriate with consideration of type of surgery and time elapsed. 2. Explore other potential sources of pain or discomfort. 3. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs. 4. Administer bolus of 25microg/kg of morphine every 15mins up to a maximum of 75micros/kg in a four-hour period as required. 5. Consider a medical review. 6. Reassess MPAT score in 30-60mins. 7. One cycle constitutes steps 1-6. 8. If MPAT pain scores remains in SEV range after completing two cycles through pathway, increase morphine by 5microgs/kg/hr and reassess MPAT score in 30-60mins. 9. If MPAT score remains in SEV range after completing three cycles through pathway, a medical review is required. Consideration for increasing morphine infusion by 5microgs/kg/hr. Reassess MPAT score 30-60mins. 10. If MPAT score remains in SEV range after completing four cycles through pathway, increase morphine by 5micros/kg/hr. 11. If non-intubated infants require a morphine infusion > 15microgs/kg/hr, a medical review is required and possible need for intubation. 12. Reassess MPAT score 30-60min. 13. If four cycles through the SEV pathway, increase morphine by 5microgs/kg/hr. 14. A medical review is required. 15. If intubated infants require a morphine infusion >30microgs/kg/hr, consider the commencement of dexmedetomidine at 0.2-0.3microgs/kg/hr if appropriate to the local context. 16. Reassess MPAT score 30-60mins 17. If MPAT score remains in SEV range despite the use of morphine at 30microgs/kg/hr and dexmedetomidine at 0.3microgs/kg/hr, the NNCA model will be suspended and the infant’s analgesic needs will be managed as per treating team according to clinical and analgesic needs of the infant. Path B (12hrs to 5 days post-operative) • If achieving a MPAT score less than or equal to 4, the infant will use LOW pathway. • If MPAT scores are between 5 and 9, the infant will use MOD pathway • If MPAT scores are greater than or equal to 10, the infant will use SEV pathway LOW pathway 1. Wean opioid rate by 20% of highest dose every 4-6hours until ceased. 2. Once opioid infusion ceased, reassess need for continuation of regular paracetamol. 3. Reassess MPAT score every 60mins for 24hrs post-operatively. 4. One cycle constitutes steps 1-3. 5. If MPAT score remains in this LOW range after this time, reassess MPAT scores every 2-4hrs until all analgesics ceased for 48hours. 6. If infant had been receiving dexmedetomidine and MPAT scores remain less than or equal to 4, consider ceasing without weaning if infusing for less than 24hrs. 7. If dexmedetomidine infusing for greater than 24hours, reduce rate by 50%. If well tolerated, cease infusion in 4-6hours after halving dose. MOD pathway 1. Pause/do not commence weaning. 2. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly skin to therapy (as appropriate with consideration of type of surgery and time elapsed. 3. Assess for other contributing factors. 4. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs. 5. Reassess pain score using MPAT every 30- 60mins. 6. One cycle constitutes steps 1-5. 12. If MPAT score remains in MOD range after 30-60mins, complete steps 1-5 again 13. If after completing two cycles through this pathway, consider returning analgesia to previous dose if weaning commenced. 14. If MPAT score remains in MOD range after completing three cycles through the pathway, return analgesia to previous dose if not done in step 13. If dose had been increased in step 13, request medical review and consider commencement of dexmedetomidine infusion at between 0.2-0.3microgs/kg/hr. Reassess MPAT score in 30-60mins and progress through steps 1-4 again. 15. If MPAT score remains in MOD range after completing four cycles through pathway, return to Path A and request a medical review. SEV pathway 1. Pause/do not commence weaning. 2. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly skin to therapy (as appropriate with consideration of type of surgery and time elapsed. 3. Assess for other contributing factors. 4. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs. 5. Reassess pain score using MPAT every 30- 60mins. 6. One cycle constitutes steps 1-5. 7. If MPAT pain score remains in MOD range after 30-60mins, progress through steps 1-5 again. 8. If after completing two cycles through this pathway, request medical review and return to Path A for continued assessment and management. Path C (equal to or greater than5 days post-operative) • If withdrawal assessment tool (WAT-1) score less than or equal to 3 and MPAT score less than or equal to 4, the infant will use green pathway. • If WAT-1 score is less than or equal to 3 and MPAT score equal to or greater than 5, infant will use pink pathway. • If WAT-1 score is equal to or greater than 3 and MPAT score is equal to or less than 4, infant will use purple pathway. • If WAT-1 score is equal to or greater than 3 and MPAT score is equal to or greater than 5, infant will use blue pathway. Green pathway 1. Wean opioid rate by 20% of highest dose daily until opioid ceased or changed to enteral therapy as per treating medical team. 2. Reassess MPAT score every 2-4hrs and WAT-1 score every 12hrs. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse. Pink pathway 1. Do not wean. 2. Maintain current opioid rate. 3. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly skin to therapy (as appropriate with consideration of type of surgery and time elapsed. 4. Consider medical review. 5. Reassess MPAT score every 2-4hrs and WAT-1 score every 12hrs. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse. 6. Reassess eligibility to wean opioid in 4-6hours. 7. One cycle constitutes steps 1-5. 8. If after completing two cycles through this pathway, request medical review. 9. Consideration for increasing opioid dose back to previous rate or administering hourly rate as a bolus. 10. If rate increased back to previous dose, maintain this rate for 24hours before considering further wean. 11. Continue to WAT-1 scores every 12hours. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse. 12. If after completing three cycles through this pathway, request medical review. 13. If WAT-1 scores remain in this range, despite increase in rate or previous bolus dose, discontinue NNCA and manage IWS as per treating medical team. Purple pathway 1. Do not wean. 2. Maintain current opioid rate. 3. Assess for other contributing factors. 4. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly skin to therapy (as appropriate with consideration of type of surgery and time elapsed. 5. Consider medical review. 6. Reassess WAT-1 score every 12hrs. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse. 7. Reassess MPAT score in 2-4hours 8. One cycle constitutes steps 1-7. 9. If after completing two cycles through this pathway, request medical review. 10. If MPAT pain score remains in the LOW range , consider weaning opioid rate by 10% of the highest dose once per day. 11. Continue to reassess MPAT pain score in 2-4hours. MPAT scoring may be completed more frequently at the discretion of the primary care nurse. 12. If after completing three cycles through this pathway, request medical review. 13. If MPAT scores remain in the LOW range but WAT-1 scores continue to be equal to or greater than 3, consider changing to enteral therapy and treating as per neonatal team. Blue pathway 1. Do not wean. 2. Maintain current opioid rate. 3. Assess for other contributing factors. 4. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly skin to therapy (as appropriate with consideration of type of surgery and time elapsed. 5. Consider medical review. 6. Reassess WAT-1 score every 12hrs. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse. 7. Reassess MPAT score in 60mins. 8. One cycle constitutes steps 1-7. 9. Request a medical review. 10. If after completing two cycles through this pathway, increase opioid rate to previous dose and or administer hourly rate as a bolus. 11. If opioid rate increased, maintain rate for 24hours before considering further wean. 12. Reassess MPAT score in 60mins. 13. If after completing three cycles through this pathway, request medical review. 14. Consider opioid increase or administration of hourly rate as a bolus. 15. Reassess MPAT score in 60mins. 16. If after completing four cycles through this pathway and WAT-1 scores and MPAT pain scores remain in this range, discontinue NNCA and manage as per treating medical team.
Sponsors
Study design
Eligibility
Inclusion criteria
Infants greater than 35 weeks gestation PMA, Infants requiring a surgical operation, Infants not requiring other pharmacological agents to manage haemostability, Opioid naïve infants or infants commenced on opioids for the first time within the previous 48hrs, Infants able to be cared for in a 1:1 allocation for the first 24hrs post-operatively. Infants in which a parent is present and able to provide informed consent.
Exclusion criteria
Infants with any Illness complicated by physical instability (e.g. Persistent Pulmonary Hypertension of the Newborn) in which additional sedation/muscle relaxation is required to manage clinical condition. Infants with complex surgical conditions (as determined by treating neonatologist) Infants with impaired hepatic or kidney function/Unconjugated hyperbilirubinaemia