Urban 2008.
| Methods | Design: Randomised controlled trial of ketamine as an adjunct to postoperative pain management after spinal fusion Date of study: Study dates not reported Power calculation: Yes Frequency of outcomes assessment: Postoperative day 1 Inclusion criteria: Patients scheduled for elective lumbar spinal fusions who were taking opioids on a daily basis Exclusion criteria: Any patients who remained at a pain numerical rating scale of 10 after 2 hours |
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| Participants | Number in study: 26 Country: USA Setting: Patients scheduled for elective lumbar spinal fusions Age: Mean age 53 years (SD 12) in intervention group, 48 years (SD 9) in control group Sex: Not reported Co‐morbidity: Not reported Dementia: Not reported |
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| Interventions | Intervention: Patients in the ketamine group received 0.2 mg/kg on induction of general anaesthesia and then 2 mcg/kg/hr until discharge from the post‐anaesthesia care unit. Control: All patients received a general anaesthetic with midazolam 5 mg, 70% nitrous oxide, 0.4% isoflurane, fentanyl at 1‐2 mcg/kg/hr and propofol at 70‐100 mg/hr. Spinal morphine (10 mcg/kg) was administered at instrumentation. |
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| Outcomes | 1) Incident delirium, measured using CAM on postoperative day 1 | |
| Notes | Funding source: Department of Anesthesia, Hospital for Special Surgery, New York Declarations of interest: Not reported Delirium not excluded at enrolment Study author conclusion: use of ketamine as an adjunct to postoperative pain management in opioid tolerant patients after spinal fusion reduced postoperative pain. There was no effect on delirium. Small trial (n = 24). Only reported delirium on postoperative day 1. Concern about the integrity of the intervention 3 in control failed their initial pain management and were converted to IV ketamine. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
| Random sequence generation (selection bias) | Low risk | Computer generated randomisation sequence |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Patients blinded but the physicians and nurses were cognitive of the groups |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors (physical therapists) blinded to allocation |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Intention‐to‐treat analysis performed as there was cross‐over between intervention and control groups. However, two patients excluded after randomised so no outcome assessment data included Any patients who remained at a numerical rating scale of 10 after 2 hours were excluded |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to assess |
| Other bias | Low risk | No evidence of other bias |