TY - JOUR
T1 - Effect of low-dose naloxone infusion on fentanyl requirements in critically ill children
AU - Darnell, Cindy Maria
AU - Thompson, Jennifer
AU - Stromberg, Daniel
AU - Roy, Lonnie
AU - Sheeran, Paul
PY - 2008/5
Y1 - 2008/5
N2 - OBJECTIVE. Sedating critically ill patients often involves prolonged opioid infusions causing opioid tolerance. Naloxone has been hypothesized to limit opioid tolerance by decreasing adenylate cyclase/cyclic adenosine monophosphate activation. The study purpose was to investigate the effect of low-dose naloxone on the maximumcumulative daily fentanyl dose in critically ill children. METHODS.We conducted a double-blinded, randomized, placebo-control trial from December 2002 through July 2004 in a university PICU. We enrolled 82 children age 1 day to 18 years requiring mechanical ventilation and fentanyl infusions anticipated to last for >4 days were eligible for enrollment. Those receiving additional oral analgesia or sedation, having a history of drug dependence or withdrawal, or having significant neurologic, renal, or hepatic disease were excluded. In addition to fent-anyl infusions, patients received low-dose naloxone or placebo infusions. Medications were adjusted using the Modified Motor Activity Assessment Scale. Withdrawal was monitored using the Modified Narcotic Withdrawal Scale. Intervention was a low-dose naloxone infusion (0.25 μg/kg per hour) and the main outcome variable was the maximum cumulative daily fentanyl dose (micrograms per kilogram per day). RESULTS. There was no difference in the maximum cumulative daily fentanyl dose between patients treated with naloxone (N=37) or those receiving placebo (N=35). Adjustment for the starting fentanyl dose also failed to reveal group differences. Total fentanyl dose received throughout the study in the naloxone group (360 μg/kg) versus placebo (223 μug/kg) was not statistically different. Placebo patients trended toward fewer rescue midazolam boluses (10.7 vs 17.8), lower total midazolam dose (11.6 mg/kg vs 23.9 mg/kg), and fewer rescue fentanyl boluses (18.5 vs 23.9). CONCLUSIONS. We conclude that administration of low-dose naloxone (0.25 μg/kg per hour) does not decrease fentanyl requirements in critically ill, mechanically ventilated children.
AB - OBJECTIVE. Sedating critically ill patients often involves prolonged opioid infusions causing opioid tolerance. Naloxone has been hypothesized to limit opioid tolerance by decreasing adenylate cyclase/cyclic adenosine monophosphate activation. The study purpose was to investigate the effect of low-dose naloxone on the maximumcumulative daily fentanyl dose in critically ill children. METHODS.We conducted a double-blinded, randomized, placebo-control trial from December 2002 through July 2004 in a university PICU. We enrolled 82 children age 1 day to 18 years requiring mechanical ventilation and fentanyl infusions anticipated to last for >4 days were eligible for enrollment. Those receiving additional oral analgesia or sedation, having a history of drug dependence or withdrawal, or having significant neurologic, renal, or hepatic disease were excluded. In addition to fent-anyl infusions, patients received low-dose naloxone or placebo infusions. Medications were adjusted using the Modified Motor Activity Assessment Scale. Withdrawal was monitored using the Modified Narcotic Withdrawal Scale. Intervention was a low-dose naloxone infusion (0.25 μg/kg per hour) and the main outcome variable was the maximum cumulative daily fentanyl dose (micrograms per kilogram per day). RESULTS. There was no difference in the maximum cumulative daily fentanyl dose between patients treated with naloxone (N=37) or those receiving placebo (N=35). Adjustment for the starting fentanyl dose also failed to reveal group differences. Total fentanyl dose received throughout the study in the naloxone group (360 μg/kg) versus placebo (223 μug/kg) was not statistically different. Placebo patients trended toward fewer rescue midazolam boluses (10.7 vs 17.8), lower total midazolam dose (11.6 mg/kg vs 23.9 mg/kg), and fewer rescue fentanyl boluses (18.5 vs 23.9). CONCLUSIONS. We conclude that administration of low-dose naloxone (0.25 μg/kg per hour) does not decrease fentanyl requirements in critically ill, mechanically ventilated children.
KW - Controlled trial
KW - Critically ill children
KW - Opiate dependent neonate
KW - Pain management
KW - Randomized
KW - Sedation
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U2 - 10.1542/peds.2007-1468
DO - 10.1542/peds.2007-1468
M3 - Article
C2 - 18411237
AN - SCOPUS:44449168790
SN - 0031-4005
VL - 121
SP - e1363-e1371
JO - Pediatrics
JF - Pediatrics
IS - 5
ER -