Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial

Duangtip Tiacharoen, Rojjanee Lertbunrian, Jarin Veawpanich, Nattanicha Suppalarkbunlue, Nattachai Anantasit, Duangtip Tiacharoen, Rojjanee Lertbunrian, Jarin Veawpanich, Nattanicha Suppalarkbunlue, Nattachai Anantasit

Abstract

Aims: The prolonged use of benzodiazepines and opioids can lead to an increase in the incidence of withdrawal syndrome. One of the known risk factors is the lack of a sedative-weaning protocol. This study established a sedative-weaning protocol and compared this protocol with the usual care of weaning in high-risk critically ill children.

Materials and methods: This was an open-label, randomized controlled trial in a tertiary-care hospital. We recruited children aged 1 month to 18 years who had received intravenous sedative or analgesic drugs for at least 5 days. The exclusion criteria were patients who had already experienced the withdrawal syndrome. We established a weaning protocol. Eligible patients were randomly divided into the protocolized (intervention) and usual care (control) groups. The primary objective was to determine the prevalence of the withdrawal syndrome compared between two groups.

Results: Thirty eligible patients were enrolled (19 in the intervention and 11 in the control group). Baseline characteristics were not significantly different between both the groups. The prevalence of the withdrawal syndrome was 84% and 81% of patients in the intervention and control group, respectively. The duration of the initial weaning phase was shorter in the intervention group than in the control group (p value = 0.026). The cumulative dose of morphine solution for rescue therapy in the intervention group was statistically lower than that in the control group (p value = 0.016).

Conclusion: The implementation of the sedative-weaning protocol led to a significant reduction in the percentage of withdrawal days and length of intensive care unit stay without any adverse drug reactions. External validation would be needed to validate this protocol.

Clinicaltrialsgov identifier: NCT03018977.

How to cite this article: Tiacharoen D, Lertbunrian R, Veawpanich J, Suppalarkbunlue N, Anantasit N. Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial. Indian J Crit Care Med 2020;24(6):451-458.

Keywords: Benzodiazepine; Critically ill children; ICU sedation; Opioid; Weaning; Withdrawal syndrome.

Conflict of interest statement

Source of support: Nil Conflict of interest: None

Copyright © 2020; Jaypee Brothers Medical Publishers (P) Ltd.

Figures

Flowchart 1
Flowchart 1
Protocol for intervention group: Initial phase. *Reduced doses 50% in patients who had renal or hepatic impairment
Flowchart 2
Flowchart 2
Protocol for intervention group: Tapering phase. *Reduced doses 50% in patients who had renal or hepatic impairment
Flowchart 3
Flowchart 3
Consolidated standards of reporting trials (CONSORT) diagram for the study. NPO, nothing per oral
Fig. 1
Fig. 1
The dosages of morphine solution during weaning period between the intervention and control group. *p value < 0.005

References

    1. Katz R, Kelly HW, Hsi A. Prospective study on the occurrence of withdrawal in critically ill children who receive fentanyl by continuous infusion. Crit Care Med. 1994;;22((5):):763––767.. doi: 10.1097/00003246-199405000-00009. DOI:
    1. Franck LS, Naughton I, Winter I. Opioid and benzodiazepine withdrawal symptoms in paediatric intensive care patients. Inten Crit Care Nurs. 2004;;20((6):):344––351.. doi: 10.1016/j.iccn.2004.07.008. DOI:
    1. Ista E, van Dijk M, Gamel C, Tibboel D, de Hoog M. Withdrawal symptoms in critically ill children after long-term administration of sedatives and/or analgesics: a first evaluation. Crit Care Med. 2008;;36((8):):2427––2432.. doi: 10.1097/CCM.0b013e318181600d. DOI:
    1. Best KM, Boullata JI, Curley MA. Risk factors associated with iatrogenic opioid and benzodiazepine withdrawal in critically ill pediatric patients: a systematic review and conceptual model. Pediatr Crit Care Med. 2015;;16((2):):175––183.. doi: 10.1097/PCC.0000000000000306. DOI:
    1. Fonsmark L, Rasmussen YH, Carl P. Occurrence of withdrawal in critically ill sedated children. Crit Care Med. 1999;;27((1):):196––199.. doi: 10.1097/00003246-199901000-00052. DOI:
    1. Fernández-Carrión F, Gaboli M, González-Celador R, Gómez de quero-Masía P, Fernández-De miguel S, Murga-Herrera V, et al. Withdrawal syndrome in the pediatric intensive care unit. incidence and risk factors. Med Intensiva. 2013;;37((2):):67––74.. doi: 10.1016/j.medine.2012.02.010. DOI:
    1. Tobias JD. Tolerance, withdrawal, and physical dependency after long-term sedation and analgesia of children in the pediatric intensive care unit. Crit Care Med. 2000;;28((6):):2122––2132.. doi: 10.1097/00003246-200006000-00079. DOI:
    1. Best KM, Asaro LA, Franck LS, Wypij D, Curley MA. Randomized evaluation of sedation titration for respiratory failure baseline study I. patterns of sedation weaning in critically ill children recovering from acute respiratory failure. Pediatr Crit Care Med. 2016;;17((1):):19––29.. doi: 10.1097/PCC.0000000000000572. DOI:
    1. Best KM, Wypij D, Asaro LA, Curley MA. Randomized evaluation of sedation titration for respiratory failure study I. patient, process, and system predictors of iatrogenic withdrawal syndrome in critically ill children. Crit Care Med. 2017;;45((1):):e7––e15.. doi: 10.1097/CCM.0000000000001953. DOI:
    1. Franck LS, Harris SK, Soetenga DJ, Amling JK, Curley MA. The withdrawal assessment tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. Pediatr Crit Care Med. 2008;;9((6):):573––580.. doi: 10.1097/PCC.0b013e31818c8328. DOI:
    1. Curley MA, Harris SK, Fraser KA, Johnson RA, Arnold JH. State behavioral scale: a sedation assessment instrument for infants and young children supported on mechanical ventilation. Pediatr Crit Care Med. 2006;;7((2):):107––114.. doi: 10.1097/01.PCC.0000200955.40962.38. DOI:
    1. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;;134((8):):663––694.. doi: 10.7326/0003-4819-134-8-200104170-00012. DOI:
    1. Oschman A, McCabe T, Kuhn RJ. Dexmedetomidine for opioid and benzodiazepine withdrawal in pediatric patients. Am J Health Syst Pharm. 2011;;68((13):):1233––1238.. doi: 10.2146/ajhp100257. DOI:
    1. Ista E, van Dijk M, Gamel C, Tibboel D, de Hoog M. Withdrawal symptoms in children after long-term administration of sedatives and/or analgesics: a literature review. “assessment remains troublesome”. Intensive Care Med. 2007;;33((8):):1396––1406.. doi: 10.1007/s00134-007-0696-x. DOI:
    1. Robertson RC, Darsey E, Fortenberry JD, Pettignano R, Hartley G. Evaluation of an opiate-weaning protocol using methadone in pediatric intensive care unit patients. Pediatr Crit Care Med. 2000;;1((2):):119––123.. doi: 10.1097/00130478-200010000-00005. DOI:
    1. Meyer MM, Berens RJ. Efficacy of an enteral 10-day methadone wean to prevent opioid withdrawal in fentanyl-tolerant pediatric intensive care unit patients. Pediatr Crit Care Med. 2001;;2((4):):329––333.. doi: 10.1097/00130478-200110000-00009. DOI:
    1. Siddappa R, Fletcher JE, Heard AM, Kielma D, Cimino M, Heard CM. Methadone dosage for prevention of opioid withdrawal in children. Paediatr Anaesth. 2003;;13((9):):805––810.. doi: 10.1046/j.1460-9592.2003.01153.x. DOI:
    1. Berens RJ, Meyer MT, Mikhailov TA, Colpaert KD, Czarnecki ML, Ghanayem NS, et al. A prospective evaluation of opioid weaning in opioid-dependent pediatric critical care patients. Anesth Analg. 2006;;102((4):):1045––1050.. doi: 10.1213/01.ane.0000202395.94542.3e. DOI:
    1. Jeffries SA, McGloin R, Pitfield AF, Carr RR. Use of methadone for prevention of opioid withdrawal in critically ill children. Can J Hosp Pharm. 2012;;65((1):):12––18.. doi: 10.4212/cjhp.v65i1.1098. DOI:
    1. Giby K, Vaillancourt R, Varughese N, Vadeboncoeur C, Pouliot A. Use of methadone for opioid weaning in children: prescribing practices and trends. Can J Hosp Pharm. 2014;;67((2):):149––156.. doi: 10.4212/cjhp.v67i2.1342. DOI:
    1. Dervan LA, Yaghmai B, Watson RS, Wolf FM. The use of methadone to facilitate opioid weaning in pediatric critical care patients: a systematic review of the literature and meta-analysis. Paediatr Anaesth. 2017;;27((3):):228––239.. doi: 10.1111/pan.13056. DOI:
    1. Honey BL, Benefield RJ, Miller JL, Johnson PN. Alpha2-receptor agonists for treatment and prevention of iatrogenic opioid abstinence syndrome in critically ill patients. Ann Pharmacother. 2009;;43((9):):1506––1511.. doi: 10.1345/aph.1M161. DOI:
    1. Srinivasan V, Pung D, O’Neill SP. Conversion from prolonged intravenous fentanyl infusion to enteral methadone in critically ill children. World J Clin Pediatr. 2017;;6((2):):110––117.. doi: 10.5409/wjcp.v6.i2.110. DOI:
    1. Carnevale FA, Ducharme C. Adverse reactions to the withdrawal of opioids and benzodiazepines in paediatric intensive care. Inten Crit Care Nurs. 1997;;13((4):):181––188.. doi: 10.1016/s0964-3397(97)80012-2. DOI:
    1. Bowens CD, Thompson JA, Thompson MT, Breitzka RL, Thompson DG, Sheeran PW. A trial of methadone tapering schedules in pediatric intensive care unit patients exposed to prolonged sedative infusions. Pediatr Crit Care Med. 2011;;12((5):):504––511.. doi: 10.1097/PCC.0b013e3181fe38f5. DOI:

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅