Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial (original) (raw)
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Efficacy and Mechanism Evaluation, 2019
Background Identifying better pain management strategies for painful procedures performed in neonatal care is a clinical priority. Retinopathy of prematurity screening and heel-lance blood tests are essential clinical procedures, but adequate pain relief is not currently provided because of a lack of evidence-based analgesia. Morphine provides effective analgesia in older children and adults, but efficacy in infants is controversial. Morphine is, however, commonly used intravenously for sedation in ventilated infants. Objective The primary objective was to investigate whether or not a single 100 µg/kg morphine sulphate dose administered orally prior to painful clinical procedures provides effective analgesia. Design Single-centre, prospective, randomised controlled trial. Setting John Radcliffe Hospital, Oxford, UK. Participants Thirty-one infants of 34–42 weeks’ gestational age, requiring a heel lance and retinopathy of prematurity screening on the same test occasion. Interventions...
Morphine compared to placebo for procedural pain in preterm infants: safety, efficacy and equipoise
Journal of Perinatology, 2019
Among nonventilated preterm infants, who are less than 32 weeks of gestation or with birth weight less than 1501 g, undergoing an eye examination to detect retinopathy of prematurity (ROP) or heel lancing, will a 0.1 mg/kg single oral dose of morphine, compared to a placebo solution, be safe, and provide analgesic efficacy demonstrated by Premature Infant Pain Profile-Revised scoring system (PIPP-R) and noxious-evoked brain activity (nEBA) while maintaining physiological stability? Methods Design: Randomized, double-blinded, placebo-controlled clinical trial.
Systematic evaluation of pain in neonates: effect on the number of intravenous analgesics prescribed
European journal of clinical pharmacology, 2003
To document the effect of systematic evaluation of pain in neonates on prescription of intravenous analgesics in a level-III neonatal intensive care unit (NICU) as a marker of increased awareness of treating and preventing pain. Retrospective analysis of the number of yearly prescribed vials of intravenous analgesics in a level-III NICU during a period before (1996-1999) and after (2000 to August 2002) introduction of a multidimensional pain scale. Correction was carried out by multiple regression analysis for clinical co-variables (admissions, days on parenteral nutrition, days on respiratory support, surgical procedures), which also might explain changes in prescription of analgesics. Postoperative length (hours) of administration of analgesics was calculated in a group of infants (1996-2001) who all received cryotherapy for threshold retinopathy of prematurity (ROP) before (1996-1999) and since (2000-2001) introduction of pain evaluation. The number of yearly prescribed vials inc...
Pain Interventions in Premature Infants: What Is Conclusive Evidence and What Is Not
Newborn and Infant Nursing Reviews, 2012
This article is the second of a two-part series that focuses on interventions to decrease pain related to common procedures in the neonatal intensive care unit. In part one, the focus was on the etiology of pain, sources of pain, short-and long-term consequences, and currently used assessment tools. In this part, an introduction of evidence-based practice is discussed, along with current pharmacologic and nonpharmacologic management strategies. Recommendations are offered on what is considered conclusive evidence and what is not.
This review assessed how often neonates in control groups experienced unnecessary pain during clinical trials involving procedural pain. We retrieved 45 studies in the 30 months up to June 2015 and found that in 29 (64%) the control babies received either placebos or no treatment. Placebos were used in 15/25 (60%) studies involving heel pricks and in 6/8 (75%) involving venepuncture. CONCLUSION: Despite international guidelines, neonates included in control groups during painful procedures do not receive analgesia in the majority of cases. Several historical reasons can explain this, but in the light of present knowledge, this should not continue. Ethical committees are thereof invited since now to not permit clinical trials that do not explicitly rule out pain during treatments and journals are invited to not publish them.
Pharmacological and nonpharmacological measures of pain management and treatment among neonates
Revista Brasileira de Terapia Intensiva, 2019
Objective: This study sought to describe and quantify the pharmacological and nonpharmacological strategies used to relieve the pain/stress of neonates during hospitalization in neonatal intensive care units. Methods: This quantitative, longitudinal, and descriptive study examined 50 neonates from neonatal intensive care unit admission to discharge. Results: A total of 9,948 painful/ stressful procedures were recorded (mean = 11.25 ± 6.3) per day per neonate. A total of 11,722 pain-management and relief interventions were performed, of which 11,495 (98.1%) were nonpharmacological strategies, and Conflicts of interest: None
Acute Pain, 2007
Background: Neonates in a neonatal intensive care unit are exposed to a high number of painful procedures. Since repeated and sustained pain can have consequences for the neurological and behaviour-oriented development of the newborn, the greatest attention needs to be paid to systematic pain management in neonatology. Non-pharmacological treatment methods are being increasingly discussed with regard to pain prevention and relief either alone or in combination with pharmacological treatment. Aims: To identify effective non-pharmacological interventions with regard to procedural pain in neonates. Methods: A literature search was conducted via the MedLine, CINAHL, Cochrane Library databases and complemented by a handsearch. The literature search covered the period from 1984 to 2004. Data were extracted according to pre-defined criteria by two independent reviewers and methodological quality was assessed. Results: 13 randomised controlled studies and two meta-analyses were taken into consideration with regard to the question of current nursing practice of non-pharmacological pain management methods. The selected interventions were ''non-nutritive suckingtucking'' do have a pain-alleviating effect on neonates. Conclusions: Some of the non-pharmacological interventions have an evident favourable effect on pulse rate, respiration and oxygen saturation, on the reduction of motor activity, and on the excitation states after invasive measures. However, unambiguous evidence of this still remains to be presented. Further research should emphasise the use of validated pain assessment instruments for the evaluation of the pain-alleviating effect of non-pharmacological interventions.
Analgesic trials in neonates: observations, pitfalls and recommendations
Paediatric and Perinatal Drug Therapy
More clinical trials are needed to study the effects of analgesics in neonates and to improve evidence based pain treatment in this group of vulnerable patients. It is not easy, however, to conduct pharmacological studies in neonates. This article explores some of the issues that may complicate clinical trials of analgesics in neonates and gives recommendations for randomised controlled trials (RCTs) in neonates in general.
Pain in neonates, assessment and management
Seminars in Neonatology, 1998
There is now widespread recognition that newborn infants both preterm and full term feel pain. There have been major developments in the assessment of neonatal pain. Multi-dimensional painscales have been developed primarily for use in full term neonates in relation to post-operative pain. There is an increased understanding of the pharmacokinetics and metabolism of analgesic drugs in the newborn. Continuous intravenous infusions of opiates such as morphine or regular oral paracetamol are established ways of treating pain.