Lenz 2008.
Methods | Study design: parallel‐group randomized controlled trial Sample size: 100 Country: Norway Setting: secondary care hospital Dates conducted: not reported Postoperative opioid used and delivery: PCA fentanyl (first 4 hours) then oxycodone 5 mg after Pain score collection: not reported Concurrent postoperative analgesics: paracetamol 2 g pre‐medication then paracetamol 1 g and diclofenac 50 mg 6 hours after pre‐medication, evening, and next morning |
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Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Group Pre (50 participants): 1.5 mcg/kg IV fentanyl before remifentanil infusion (at induction) and 10 minutes before the end of surgery (3 mcg/kg in total) Group Post (50 participants): saline placebo at induction and 3 mcg/kg IV fentanyl 10 minutes before the end of surgery |
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Outcomes |
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Notes | Funding: departmental funding Declarations of interest: 2 authors received compensation for lectures from GlaxoSmithKline. Authors contacted: we contacted authors for further information and received a response, however no further data were available. Other: opioid consumption data extracted from graph using computer software. Pain reported as median so included in narrative synthesis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated codes. Quote: "randomization was based on computer‐generated codes" |
Allocation concealment (selection bias) | Low risk | Quote: "stored in sequentially numbered, sealed envelopes. A nurse not participating in the handling or the evaluation of the participant was responsible for opening the envelopes and preparing the two coded syringes" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Group Pre, both syringes contained fentanyl 1.5 mg/kg for participant’s weight. In Group Post, syringe no. 1 contained 0.9% saline (placebo) and syringe no. 2 contained fentanyl 3.0 mg/kg based on participant’s weight. Saline was used for dilution so that the syringes contained the same volume for participants with the same weight" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Likely blinded based on above information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Exclusions unlikely to cause bias. Quote: "from 112 participants, 12 were excluded because the surgical procedure did not proceed to repair as planned" |
Selective reporting (reporting bias) | Low risk | NCT00241332. Primary outcomes pre‐stated. Quote: "the study was reported to ClinicalTrials.gov ID: NCT00241332" |
Other bias | Low risk | Similar groups and no industry funding. Quote: "the demographic characteristics of these 100 patients were similar in the two groups" |