Morad 2012.
| Study characteristics | ||
| Methods | Parallel, outcomes assessed until participants discharged from neuroscience critical care unit or the collection of 16 h of data | |
| Participants | PCA 40, control 40 Elective posterior fossa surgery: suboccipital craniectomy for Chiari‐type malformations (34% of patients), craniectomy for acoustic neuroma (35% of patients), and suboccipital craniotomy for other pathologies (31% of patients) |
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| Interventions | PCA: fentanyl. Bolus/lockout/1 h limit: 0.5 µg/kg (max dose 50 µg)/15 min/4 demand dose per h Control: IV fentanyl 25 µg to 50 µg every 30 min prn |
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| Outcomes | Pain intensity at rest, opioid consumption, changes in neurologic status with Glasgow Coma Scale, Ramsay Sedation Scale, the number of emergency postoperative imaging studies obtained for evaluation of neurologic changes, incidence of pruritus/nausea and vomiting, vital signs | |
| Source of funding | Financial support from the Jacob and Hilda Blaustein Foundation and the Richard J. Traystman Endowed Chair | |
| Notes | QS = 3 (R = 2, DB = 0, W = 1) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Group assignment was determined using a randomization scheme with random block lengths generated by the medical centre’s research pharmacy service." |
| Allocation concealment (selection bias) | Low risk | "Group assignments were communicated electronically by the research pharmacy service to the study coordinator after informed consent was obtained" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The surgical and anesthesia teams were masked to group assignments, but participants and nurses were not |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar number of dropouts in each group: PCA 6 dropouts, 5 prior to intervention, control 9 dropouts, 7 prior to intervention Final number of patients analyzed: PCA 34, control 31. Majority of dropouts occurred during operative phase, before participants received intervention Per protocol analysis, but majority of protocol violations also occurred before interventions administered |
| Selective reporting (reporting bias) | Unclear risk | Protocol (but not results) posted on clinicaltrials.gov – mentions outcomes of patient satisfaction and time to discharge. Neither reported in paper. Otherwise, all outcomes mentioned in Methods reported in Results |
| Other bias | Unclear risk | Small sample size |