66895
document
The addition of tramadol to the standard of i.v . acetaminophen and morphine infusion for postoperative analgesia in neonates offers no clinical benefit : a randomized placebo-controlled trial . BACKGROUND Tramadol is used following neonatal cardiac and general surgery . However , its ability to opioid-spare or facilitate earlier extubation in postoperative neonates is unquantified . OBJECTIVE This randomized placebo-controlled trial aimed to assess whether tramadol 's addition to standard analgesia resulted in earlier extubation or reduced analgesic/sedative requirements in postsurgical neonates . METHODS Neonates born ≥32 weeks postmenstrual age received either tramadol [ T ] 2 mg·kg ( -1 ) or placebo [ P ] 6-hourly for up to 5 days postthoracoabdominal surgery in addition to morphine ( commenced at 20 mcg·kg ( -1 ) ·h ( -1 ) ) and 6-hourly i.v . acetaminophen . Time to extubation , morphine and midazolam amounts , hourly pain scores , and seizure activity were compared using an intention-to-treat and per-protocol analysis . RESULTS Seventy-one neonates participated . Median survival time to extubation was similar between the groups ( T 67 h [ 95 % CI 51 , 84 ] vs P 52 h [ 95 % CI 43 , 65 ] ; P = 0.4 ) , and similar numbers were extubated by 96 h ( T 69 % vs P 77 % ; difference -8 % , 95 % CI -28 , 13 % ) . Morphine and midazolam exposure was similar , with low pain scores in both groups ( mean percentage of time with a pain score > 5/20 during the 5 days : T 13 % vs P 11 % , difference in means 2.8 [ 95 % CI -1.8 , 7.6 ] , P = 0.20 ) . Most participants had normal cranial ultrasounds ( T 86 % vs P 86 % ) ; no seizures occurred clinically or electroencephalographically . CONCLUSION Tramadol 's addition to standard analgesia in this small group of postsurgical neonates did not appear to have any positive effect on time to extubation , morphine or midazolam exposure , or pain scores . This questions the benefit of tramadol for postsurgical neonates . Importantly , no seizures occurred in these ill neonates who may potentially be at greater risk of tramadol toxicity compared with adults .
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Intervention_Pharmacological
tramadol
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Intervention_Pharmacological
acetaminophen and morphine
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
Tramadol
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Intervention_Pharmacological
tramadol 's
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Intervention_Control
standard analgesia
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Intervention_Pharmacological
tramadol
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Intervention_Control
placebo
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Outcome_Physical
acetaminophen
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Outcome_Physical
Time to extubation
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Outcome_Physical
morphine and midazolam amounts
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Outcome_Physical
hourly pain scores
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Outcome_Physical
seizure activity
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Outcome_Mental
participated
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Outcome_Other
Median survival time to extubation
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Outcome_Pain
with low pain scores
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Outcome_Pain
with a pain score
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Outcome_Physical
normal cranial ultrasounds
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Outcome_Physical
86 % ) ; no seizures
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Outcome_Physical
effect on time to extubation
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Outcome_Physical
morphine or midazolam exposure
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Outcome_Pain
pain scores
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Participant_Condition
postoperative analgesia in neonates
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Participant_Condition
neonatal cardiac
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Participant_Condition
general surgery .
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Participant_Condition
postsurgical neonates
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Participant_Condition
postthoracoabdominal surgery
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Participant_Sample-size
Seventy-one
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Participant_Age
with adults