Intravenous Paracetamol in Adjunct to Intravenous Ketoprofen for Postoperative Pain in Children Undergoing General Surgery: A Double-Blinded Randomized Study

<i>Background and objectives:</i> The combination of non-steroidal anti-inflammatory drugs and paracetamol is widely used for pediatric postoperative pain management, although the evidence of superiority of a combination over either drug alone is insufficient. We aimed to find out if int...

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Main Authors: Danguolė Rugytė, Jūratė Gudaitytė
Format: Article
Language:English
Published: MDPI AG 2019-04-01
Series:Medicina
Subjects:
Online Access:https://www.mdpi.com/1010-660X/55/4/86
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author Danguolė Rugytė
Jūratė Gudaitytė
author_facet Danguolė Rugytė
Jūratė Gudaitytė
author_sort Danguolė Rugytė
collection DOAJ
description <i>Background and objectives:</i> The combination of non-steroidal anti-inflammatory drugs and paracetamol is widely used for pediatric postoperative pain management, although the evidence of superiority of a combination over either drug alone is insufficient. We aimed to find out if intravenous (i.v.) paracetamol in a dose of 60 mg kg<sup>&#8722;1</sup> 24 h<sup>&#8722;1</sup>, given in addition to i.v. ketoprofen (4.5 mg kg<sup>&#8722;1</sup> 24 h<sup>&#8722;1</sup>), improves analgesia, physical recovery, and satisfaction with postoperative well-being in children and adolescents following moderate and major general surgery. <i>Materials and Methods:</i> Fifty-four patients were randomized to receive either i.v. paracetamol or normal saline as a placebo in adjunct to i.v. ketoprofen. For rescue analgesia in patients after moderate surgery, i.v. tramadol (2 mg kg<sup>&#8722;1</sup> up two doses in 24 h), and for children after major surgery, i.v. morphine-patient-controlled analgesia (PCA) were available. The main outcome measure was the amount of opioid consumed during the first 24 h after surgery. Pain level at 1 and over 24 h, time until the resumption of normal oral fluid intake, spontaneous urination after surgery, and satisfaction with postoperative well-being were also assessed. <i>Results:</i> Fifty-one patients (26 in the placebo group and 25 in the paracetamol group) were studied. There was no difference in required rescue tramadol doses (<i>n</i> = 11 in each group) or 24-h morphine consumption (mean difference (95% CI): 0.06 (&#8211;0.17; 0.29) or pain scores between placebo and paracetamol groups. In patients given morphine-PCA, time to normal fluid intake was faster in the paracetamol than the placebo subgroup: median difference (95% CI): 7.5 (1.3; 13.7) h, <i>p</i> = 0.02. Parental satisfaction score was higher in the paracetamol than the placebo group (mean difference: &#8211;1.3 (&#8211;2.5; &#8211;0.06), <i>p</i> = 0.04). <i>Conclusions:</i> There were no obvious benefits to opioid requirement or analgesia of adding regular intravenous paracetamol to intravenous ketoprofen in used doses. However, intravenous paracetamol may contribute to faster recovery of normal functions and higher satisfaction with postoperative well-being.
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spelling doaj.art-884541b16a8d470f84686da8495348d72023-09-02T16:29:02ZengMDPI AGMedicina1010-660X2019-04-015548610.3390/medicina55040086medicina55040086Intravenous Paracetamol in Adjunct to Intravenous Ketoprofen for Postoperative Pain in Children Undergoing General Surgery: A Double-Blinded Randomized StudyDanguolė Rugytė0Jūratė Gudaitytė1Department of Anesthesiology, Lithuanian University of Health Sciences, 44307 Kaunas, LithuaniaDepartment of Anesthesiology, Lithuanian University of Health Sciences, 44307 Kaunas, Lithuania<i>Background and objectives:</i> The combination of non-steroidal anti-inflammatory drugs and paracetamol is widely used for pediatric postoperative pain management, although the evidence of superiority of a combination over either drug alone is insufficient. We aimed to find out if intravenous (i.v.) paracetamol in a dose of 60 mg kg<sup>&#8722;1</sup> 24 h<sup>&#8722;1</sup>, given in addition to i.v. ketoprofen (4.5 mg kg<sup>&#8722;1</sup> 24 h<sup>&#8722;1</sup>), improves analgesia, physical recovery, and satisfaction with postoperative well-being in children and adolescents following moderate and major general surgery. <i>Materials and Methods:</i> Fifty-four patients were randomized to receive either i.v. paracetamol or normal saline as a placebo in adjunct to i.v. ketoprofen. For rescue analgesia in patients after moderate surgery, i.v. tramadol (2 mg kg<sup>&#8722;1</sup> up two doses in 24 h), and for children after major surgery, i.v. morphine-patient-controlled analgesia (PCA) were available. The main outcome measure was the amount of opioid consumed during the first 24 h after surgery. Pain level at 1 and over 24 h, time until the resumption of normal oral fluid intake, spontaneous urination after surgery, and satisfaction with postoperative well-being were also assessed. <i>Results:</i> Fifty-one patients (26 in the placebo group and 25 in the paracetamol group) were studied. There was no difference in required rescue tramadol doses (<i>n</i> = 11 in each group) or 24-h morphine consumption (mean difference (95% CI): 0.06 (&#8211;0.17; 0.29) or pain scores between placebo and paracetamol groups. In patients given morphine-PCA, time to normal fluid intake was faster in the paracetamol than the placebo subgroup: median difference (95% CI): 7.5 (1.3; 13.7) h, <i>p</i> = 0.02. Parental satisfaction score was higher in the paracetamol than the placebo group (mean difference: &#8211;1.3 (&#8211;2.5; &#8211;0.06), <i>p</i> = 0.04). <i>Conclusions:</i> There were no obvious benefits to opioid requirement or analgesia of adding regular intravenous paracetamol to intravenous ketoprofen in used doses. However, intravenous paracetamol may contribute to faster recovery of normal functions and higher satisfaction with postoperative well-being.https://www.mdpi.com/1010-660X/55/4/86painpostoperativechildnon-opioid analgesicsrecovery of functionpatient satisfaction
spellingShingle Danguolė Rugytė
Jūratė Gudaitytė
Intravenous Paracetamol in Adjunct to Intravenous Ketoprofen for Postoperative Pain in Children Undergoing General Surgery: A Double-Blinded Randomized Study
Medicina
pain
postoperative
child
non-opioid analgesics
recovery of function
patient satisfaction
title Intravenous Paracetamol in Adjunct to Intravenous Ketoprofen for Postoperative Pain in Children Undergoing General Surgery: A Double-Blinded Randomized Study
title_full Intravenous Paracetamol in Adjunct to Intravenous Ketoprofen for Postoperative Pain in Children Undergoing General Surgery: A Double-Blinded Randomized Study
title_fullStr Intravenous Paracetamol in Adjunct to Intravenous Ketoprofen for Postoperative Pain in Children Undergoing General Surgery: A Double-Blinded Randomized Study
title_full_unstemmed Intravenous Paracetamol in Adjunct to Intravenous Ketoprofen for Postoperative Pain in Children Undergoing General Surgery: A Double-Blinded Randomized Study
title_short Intravenous Paracetamol in Adjunct to Intravenous Ketoprofen for Postoperative Pain in Children Undergoing General Surgery: A Double-Blinded Randomized Study
title_sort intravenous paracetamol in adjunct to intravenous ketoprofen for postoperative pain in children undergoing general surgery a double blinded randomized study
topic pain
postoperative
child
non-opioid analgesics
recovery of function
patient satisfaction
url https://www.mdpi.com/1010-660X/55/4/86
work_keys_str_mv AT danguolerugyte intravenousparacetamolinadjuncttointravenousketoprofenforpostoperativepaininchildrenundergoinggeneralsurgeryadoubleblindedrandomizedstudy
AT jurategudaityte intravenousparacetamolinadjuncttointravenousketoprofenforpostoperativepaininchildrenundergoinggeneralsurgeryadoubleblindedrandomizedstudy