Wood 1998.
| Study characteristics | ||
| Methods | Single‐centre double‐blind randomised controlled trial | |
| Participants | 88 babies were eligible Inclusion criteria: neonates less than 35 weeks' PMA at birth, greater than 2 hours but less than 48 hours old at trial entry; who required IPPV (intermittent positive‐pressure ventilation) and therefore sedation. An indwelling intra‐arterial access was needed as an inclusion criterion Exclusion criteria: early neonatal surgery; severe congenital malformation; previous administration of opiates | |
| Interventions | Morphine group (n = 44): 200 mcg/kg over 2 hours, followed by maintenance infusion of 25 mcg/kg/hour Diamorphine group (n = 44): 120 mcg/kg over 2 hours, then 15 mcg/kg/hour | |
| Outcomes | Mean arterial blood pressure (MABP); coefficient of variation (CV) of 10 successive systolic blood pressure values; sedation level (by a 4‐parameter sedation score and a qualitative judgement) recorded at 0, 2, 6, and 24 hours into the infusion; plasma concentrations of adrenaline and noradrenaline evaluated at 0 and 24 hours Duration of infusion (hours); days of MV; IVH (all grades); parenchymal brain lesions; air leak; PDA; oxygen required at 28 days; death (up to 28 days) also recorded | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation was not stated |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not stated |
| Blinding of participants and personnel (performance bias) | Low risk | Clinicians, nurses, and parents were blinded to randomisation. Infusion solutions were made up by the hospital pharmacy in identically presented syringes |
| Blinding of outcome assessment (detection bias) | Low risk | Trial was stated to be double‐blinded: probably done (clinicians and nurses were blinded) |
| Incomplete outcome data (attrition bias) | High risk | For many outcomes, data for almost 50% of infants were missing |
| Selective reporting (reporting bias) | Unclear risk | Trial not registered; protocol not available |
| Other bias | Low risk | Study appears to be free of other sources of bias |
ABP: arterial blood pressure; BP: blood pressure; BPD: bronchopulmonary dysplasia; bpm: beats per minute; CBCL: Child Behavior Checklist; CDCC: Child Development Center of China; CFM: cerebral function monitoring; CHIPPS: Children and Infants Postoperative Pain Scale; CLD: chronic lung disease; CNS: central nervous system; CPAP:continuous positive airway pressure; CV: coefficient of variation; DQ: developmental quotient; EDIN: Échelle de Douleur et d'Inconfort du Nouveau‐né; FiO₂: fraction of inspired oxygen: GA: gestational age; GOT: glutamate‐oxaloacetate‐transferase; HR: heart rate; IPPV: intermittent positive‐pressure ventilation; IQ: intelligence quotient; ITT: intention‐to‐treat; i.v.: intravenous; IVH: intraventricular haemorrhage; MABP: mean arterial blood pressure; MAP: mean arterial pressure; MBP: mean arterial blood pressure; min: minutes; MDI: mental development index; MV: mechanical ventilation; N‐PASS: Neonatal Pain, Agitation and Sedation Scale; NAPI: Neurobehavioral Assessment of the Preterm Infant; NEC: necrotising enterocolitis; NFCS: Neonatal Facial Coding System; NICU: neonatal intensive care unit; NIPS: Neonatal‐Infant Pain Scale; NOPAIN: Neonatal Outcome and Prolonged Analgesia in Neonates; NSE: neuron‐specific enolase; PDA: patent ductus arteriosus; PDI: psychomotor development index; PEEP: positive end‐expiratory pressure; PICU: paediatric intensive care unit; PIP: peak inspiratory pressure; PIPP: premature infant pain profile; PMA: post‐menstrual age; PPHN: persistent pulmonary hypertension of the newborn; PVL: periventricular leukomalacia; RDS: respiratory distress syndrome; RR: respiratory rate; SNAP score: Score for Neonatal Acute Physiology; TISS: Therapeutic Intervention Scoring System.