Bouwmeester 2003b.
| Study characteristics | ||
| Methods |
Study design: Double‐blind, randomized clinical trial Study grouping: Continuous morphine versus three‐hourly placebo or intermittent morphine with placebo infusion. Additional morphine was administered on the guidance of clinicians if they considered the infant was in pain. |
|
| Participants |
Baseline Characteristics: Neonates aging from 0 to 4 weeks (gestational age between 35 and 42 weeks; body weight 1500 g or more) Overall Inclusion criteria: Included neonates were admitted to the surgical intensive care unit following thoracic or abdominal surgery. Exclusion criteria: Neonates with neurological, renal, or hepatic dysfunction, or with opioid therapy less than 6 hours prior to surgery were excluded. Pretreatment: Anesthesia was induced intravenously with 3 to 5 mg/kg thiopentone or by inhalation with halothane in oxygen. Fentanyl at 5 mcg/kg was given before orotracheal intubation, which was facilitated with 0.5 to 1 mg/kg atracurium or 2 mg/kg suxamethonium. |
|
| Interventions |
Intervention Characteristics Continuous infusion versus bolus administration
|
|
| Outcomes |
Pain assessed with validated methods during the administration of selected drugs
Pain was assessed by trained nurses before surgery and every 3 h for 24 h after surgery using the validated behavioral Comfort scale (CS; total scores range from 6 to 30) and visual analogue scale (VAS; ranging from 0 to 10). |
|
| Identification |
Sponsorship source: The study was supported by the Netherlands Research Council and the Sophia Foundation for Medical Research. Country: The Netherlands Setting: Pediatric Intensive Care Unit Comments: None Authors names: Nancy J. Bouwmeester, Wim C. J. Hop, Monique van Dijk, K.J.S. Anand, John N. van den Anker, and Dick Tibboel Institution: Department of Anesthesiology and Pediatric Surgery, Sophia Children's Hospital Email: j.bouwmeester.1@erasmusmc.nl Address: Sophia Children's Hospital, University Hospital Rotterdam, Dr Molewaterplein 60, 3015 GJ Rotterdam, The Netherlands |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "All neonates received a dose of morphine hydrochloride 100 µg/kg at the end of surgery and were randomly allocated to equivalent intravenous doses of continuous morphine infusions (CM, 10 µg/kg per hour) or intermittent morphine boluses (IM, 30 µg/kg per 3 hours)." Not specified further |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not a blinded trial. Not described in the paper; the difference in the protocol can be visually noticed. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | "Pain was assessed by trained nurses before surgery and every 3 h for 24 h after surgery using the validated behavioral Comfort scale (CS; total scores range from 6 to 30) and visual analogue scale (VAS; ranging from 0 to 10)." Not a blinded trial. The difference in the protocol is visually apparent; other outcomes besides pain assessment were objective (plasma concentrations, etc.). |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Six patients were excluded from morphine analysis, five because of detectable plasma morphine levels at baseline and one because of loss of the arterial line at the end of surgery. The five patients with detectable morphine concentrations at time 0 had received morphine more than 6 h before surgery." "Hemodynamic data could not be analyzed in 3 of the 68 neonates due to loss of the arterial line during the study." No major concern |
| Selective reporting (reporting bias) | Unclear risk | No registry reported so unable to compare with protocol |
| Other bias | Low risk | None |