Intravenous acetaminophen for postoperative pain in the neonatal intensive care unit: A protocol for a pilot randomized controlled trial (IVA POP)
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SUBMITTER: Archer V
PROVIDER: S-EPMC10659208 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:Preterm infants (PTI) typically experience many painful and stressful procedures or events during their first weeks of life in a neonatal intensive care unit, and these can profoundly impact subsequent brain development and function. Several protective interventions during this sensitive period stimulate the oxytocin system, reduce pain and stress, and improve brain development. This review provides an overview of the environmental risk factors experienced by PTI during hospitalization, with a focus on the effects of pain, and early maternal separation. We also describe the long-term adverse effects of the simultaneous experiences of pain and maternal separation, and the potential beneficial effects of maternal vocalizations, parental contact, and several related processes, which appear to be mediated by the oxytocin system.
| S-EPMC6454868 | biostudies-literature
Project description:BackgroundConcerns regarding potential risk of dermal irritation have led to the exclusion of NICU patients from the recommendation regarding the use of 2% chlorhexidine gluconate (CHG) wash for daily skin cleansing to reduce bloodstream infections. Our aim was to assess the safety of 2% CHG bathing in NICU patients.MethodsThe regulator required a stepwise study enrollment to three successive groups: term infants, followed by near-term and pre-term infants. For comparison, we used a cohort of matched controls. A propensity score-adjusted regression model was used to compare the groups.InterventionInfants were bathed thrice-weekly with 2% CHG-impregnated washcloths. Participant's skin was examined daily.ResultsOver a total of 661 days of treatment: 384,129, and 148 days for the term, near-term and pre-term groups, respectively, no skin reactions were observed. The intervention group was generally sicker, however, bloodstream infections were similar between the groups.ConclusionFor infants >30 weeks and >3 days old, 2% CHG bathing was safe. Large multicenter studies are urgently needed to establish the effectiveness of this practice in the NICU.
| S-EPMC10035923 | biostudies-literature
Project description:Intravenous administration of acetaminophen is an alternative to the oral and rectal routes, which may be contraindicated in particular clinical settings. This randomized, placebo-controlled study of intravenous acetaminophen (Ofirmev, Mallinckrodt Pharmaceuticals, Bedminster, New Jersey) in neonate and infant patients with acute postoperative pain assessed pharmacokinetics (PK) and safety, in addition to efficacy and pharmacodynamics of repeated doses administered over 24 hours. Neonate and infant patients (<2 years of age) who were undergoing surgery or had experienced a traumatic injury and were expected to need pain management for at least 24 hours were enrolled. Subjects were randomly assigned to receive intravenous acetaminophen low dose, intravenous acetaminophen high dose, or placebo. A population PK model of intravenous acetaminophen was updated by combining 581 samples from the current study of 158 neonate and infant subjects with results from a previously developed model. The individual predicted-versus-observed concentrations plots showed that the structural PK model fit the blood and plasma acetaminophen concentration-versus-time profiles in the active and placebo groups. Terminal elimination half-life was prolonged in neonates and younger infants and in intermediate and older infants similar to values in adults. When compared with placebo, total rescue opioid consumption was similar and significantly fewer intravenous acetaminophen patients prematurely discontinued because of treatment-emergent adverse events (P < .01). For intravenous acetaminophen, neonates receiving 12.5 mg/kg every 6 hours had PK profiles similar to younger, intermediate, and older infants, adolescents, and adults weighing <50 kg receiving 15 mg/kg every 6 hours and adults ≥ 50 kg receiving 1000 mg every 6 hours.
| S-EPMC6973014 | biostudies-literature
Project description:ObjectivesDespite credible evidence, optimal neonates' pain management in the neonatal intensive care unit (NICU) is a challenging issue. In this regard, the organisational context is an essential factor. The existing challenges vary depending on the context, and investigating them can help to improve the quality of care. The study aimed to explore organisational challenges to neonates' pain management in the NICU.MethodsThis qualitative study included 31 nurses and physicians in the NICU of Children's Hospital, Tabriz, Iran. Data collection was done through individual and focus group interviews. For data analysis, we used conventional content analysis.ResultsThe identified challenges included organisational culture (poor interprofessional collaboration and low parental participation), organisational structure (lack of unified approach in relieving pain and limited supervision for pain management) and organisational resources (lack of time due to high workload and inadequate educational programmes).ConclusionsMany organisational factors consistently affect neonatal pain management. Adopting some approaches to enhance the cooperation of treatment team members, holding educational programmes, proper organisational supervision and implementing a unified neonatal-based pain management programme could improve neonatal pain management.
| S-EPMC10481740 | biostudies-literature
Project description:ImportanceIntravenous acetaminophen is a commonly prescribed analgesic for the prevention and treatment of postsurgical pain. Its efficacy in the context of endoscopic sinus surgery (ESS) has yielded mixed results.ObjectiveTo compare the efficacy of perioperative intravenous acetaminophen (IVAPAP) with that of placebo in improving early postoperative pain after endoscopic sinus surgery (ESS).Design, setting, and participantsA prospective, randomized clinical trial including 62 patients undergoing ESS for chronic rhinosinusitis in a single tertiary referral hospital.InterventionsParticipants were randomized to receive 1 g of IVAPAP or 100 mL of placebo consisting of saline infusions immediately before the start of surgery and 4 hours after the initial dose.Main outcomes and measuresThe primary outcome was postoperative pain measured by visual analog scale (VAS) scores up to 24 hours after surgery by blinded observers. Secondary endpoints included postoperative opioid (intravenous and oral) use and adverse events in the 24-hour postoperative period.ResultsOf the 62 enrolled adult participants, 60 were randomized (31 to IVAPAP intervention and 29 to placebo). The mean (SD) age of participants was 53.7 (14.7) years and 35 (58%) of the participants were men and 25 (42%) were women. Within the first hour, mean pain scores were reduced in the IVAPAP group compared with the control group, reaching a maximum difference of 7.7 mm on a VAS scale favoring the treatment group with a true difference possibly as high as 22 mm, and the data are compatible with a clinically meaningful difference. At 12- and 24-hours, average pain scores were less in the placebo group and the data are compatible with a clinically meaningful difference of 5.8 (-5.2 to 16.8) and 8.2 (-1.9 to 18.4), respectively, favoring the placebo group. However, at all time points the CIs included the null value and were wide, thus preventing definitive conclusions. Inspection of the secondary outcomes favored IVAPAP, but the wide range of the CIs and inclusion of the null value prevent definitive conclusions.Conclusions and relevanceThe results of this study are inconclusive. The data suggest that perioperative intravenous acetaminophen may reduce immediate postoperative pain and opioid requirements compared with placebo and these differences could be clinically meaningful. Unfortunately, the imprecision of the estimates prevents definitive conclusion. Use of IVAPAP does not seem to increase adverse events.Trial registrationclinicaltrials.gov Identifier: NCT01608308.
| S-EPMC5710551 | biostudies-literature
Project description:AimTo investigate the frequency, etiology, and current management strategies for diarrhea in newborn.MethodsRetrospective, nationwide study involving 5801 subjects observed in neonatal intensive care units during 3 years. The main anamnesis and demographic characteristics, etiology and characteristics of diarrhea, nutritional and therapeutic management, clinical outcomes were evaluated.ResultsThirty-nine cases of diarrhea (36 acute, 3 chronic) were identified. The occurrence rate of diarrhea was 6.72 per 1000 hospitalized newborn. Etiology was defined in 29 of 39 newborn (74.3%): food allergy (20.5%), gastrointestinal infections (17.9%), antibiotic-associated diarrhea (12.8%), congenital defects of ion transport (5.1%), withdrawal syndrome (5.1%), Hirschsprung's disease (2.5%), parenteral diarrhea (2.5%), cystic fibrosis (2.5%), and metabolic disorders (2.5%). Three patients died due to complications related to diarrhea (7.7%). In 19 of 39 patients (48.7%), rehydration was performed exclusively by the enteral route.ConclusionDiarrhea in neonates is a challenging clinical condition due to the possible heterogeneous etiologies and severe outcomes. Specific guidelines are advocated in order to optimize management of diarrhea in this particular setting.
| S-EPMC2880780 | biostudies-literature
Project description:ObjectivesTo measure the feasibility, reach, and potential impact of a virtual family-centered rounds (FCR) intervention in the neonatal intensive care unit.MethodsWe conducted a randomized controlled pilot trial with a 2:1 intervention-to-control arm allocation ratio. Caregivers of intervention arm neonates were invited to participate in virtual FCR plus standard of care. We specified 5 feasibility objectives. We profiled intervention usage by neonatal and maternal characteristics. Exploratory outcomes included FCR caregiver attendance, length of stay, breast milk feeding at discharge, caregiver experience, and medical errors. We performed descriptive analyses to calculate proportions, means, and rates with 95% confidence intervals (CI).ResultsWe included 74 intervention and 36 control subjects. Three of the five feasibility objectives were met based on the point estimates. The recruitment and intervention uptake objectives were not achieved. Among intervention arm subjects, recruitment of a caregiver occurred for 47 (63.5%, 95% CI 51.5%-74.4%) neonates. Caregiver use of the intervention occurred for 36 (48.6%, 95% CI 36.8%-60.6%) neonates in the intervention arm. Feasibility objectives assessing technical issues, burden, and data collection were achieved. Among the attempted virtual encounters, 95.0% (95% CI 91.5%-97.3%) had no technical issues. The survey response rate was 87.5% (95% CI 78.2%-93.8%). Intervention arm neonates had 3.36 (95% CI 2.66%-4.23) times the FCR caregiver attendance rate of subjects in the control arm.ConclusionsA randomized trial to compare virtual FCR to standard of care in neonatal subjects is feasible and has potential to improve patient and caregiver outcomes.
| S-EPMC8429071 | biostudies-literature
Project description:BackgroundNeonates in the neonatal intensive care unit (NICU) undergo a multitude of painful and stressful procedures during the first days of life. Stress from this pain can lead to neurodevelopmental problems that manifest in later childhood and should be prevented.ObjectiveTo determine the number of painful procedures performed per day for each neonate, to verify documentation of painful procedures performed, and to, subsequently, note missed opportunities for providing pain relief to neonates.MethodsWe conducted a cross-sectional study at a level III NICU located in a rural part of western India. A total of 69 neonates admitted for more than 24 h were included. Twenty-nine neonates were directly observed for a total of 24 h each, and another 40 neonatal records were retrospectively reviewed for the neonate's first 7 days of admission. All stressful and painful procedures performed on the neonate were recorded. Also recorded were any pharmaceutical pain relief agents or central nervous system depressants administered to the neonate before or at the time of the procedures. Average nurse-patient ratio was also calculated. Data were analyzed using descriptive statistics.ResultsA documentation deficit of 2.2% was observed. The average nurse-patient ratio was 1.53:1. A total of 13711 procedures were recorded, yielding 44.1 (38.1 stressful, 3.8 mildly painful, and 2.2 moderately painful) procedures per patient day. Common stressful procedures were position changing (2501) and temperature recording (2208). Common mildly and moderately painful procedures were heel prick (757) and endotracheal suctioning (526), respectively. Use of pharmacological agents coincided with 33.48% of the procedures. The choice of drug and time of administration were inappropriate, indicating that the pharmacological agents were intended not for pain relief but rather for a coexisting pathology or as sedation from ventilation with no analgesia.ConclusionStressful procedures are common in the NICU; mildly and moderately painful procedures fairly common. Almost two-thirds of the times, no pharmaceutical pain relief methods were used, and when administered, the pharmaceutical agents were seldom intended for pain relief; this implies poor pain management practices and emphasizes the imperative need for educating NICU nurses, residents, fellows, and attendings.
| S-EPMC4763094 | biostudies-literature
Project description:BackgroundTo evaluate the procedural pain experienced by neonates in a neonatal intensive care unit (NICU) setting and determine the corresponding pain grades.MethodsTwo experienced nurses independently used the Neonatal Infant Pain Scale (NIPS) to evaluate the neonatal pain during procedures taking place in the tertiary NICU and two level-two neonatal care units in the Children's Hospital of Zhejiang University School of Medicine. The mean and distribution of NIPS pain scores and the corresponding pain grades of participants when experiencing clinical painful procedures were analysed.ResultsA total of 957 neonates exposed to 15 common clinical painful procedures were included in the study. The clinical painful procedures experienced by 957 participants could be divided into three groups: severe pain (NIPS score 5-7: peripheral intravenous cannulation, arterial catheterisation, arterial blood sampling, peripherally inserted central catheter placement and nasopharyngeal suctioning), mild to moderate pain (NIPS score 3-4: finger prick, intramuscular injection, adhesive removal, endotracheal intubation suctioning, heel prick, lumbar puncture and subcutaneous injection) and no pain to mild pain (NIPS score 0-2: gastric tube insertion, enema and intravenous injection).ConclusionsThe neonatal pain response to clinical procedures in NICU had certain pattern and preintervention drug analgesia could be taken for painful procedures with clustered high NIPS pain scores. Meanwhile, full coverage non-drug pain relief measures could be taken for procedures that are with scattered pain scores, and real-time pain evaluation should be provided to determine whether further drug analgesia is required.
| S-EPMC10582867 | biostudies-literature