Gabbott 1997.
Study characteristics | ||
Methods | Study design: parallel‐group randomized controlled trial
Sample size: 65
Country: UK
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: PCA morphine Pain score collection: trained nurse Concurrent postoperative analgesics: none reported |
|
Participants |
Inclusion criteria
Exclusion criteria
|
|
Interventions |
Group D (34 participants): IM ketorolac 30 mg 45‐90 minutes preoperatively and placebo at incision Group B (31 participants): IM ketorolac 30 mg at incision and placebo 45‐90 minutes preoperatively |
|
Outcomes |
|
|
Notes | Funding: not reported Declarations of interest: not reported Authors contacted: yes Other: unable to use any data due to different time points, lack of reporting and inability to convert the scales used |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear whether a truly random process. Quote: "Randomization was achieved by allocating each patient the next numbered pair of study ampoules". |
Allocation concealment (selection bias) | Unclear risk | Pharmacy‐controlled but in view of above unclear. Quote: "The code determining the contents of each ampoule was kept by the pharmacy department and not released to the investigators until after the study was terminated". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐dummy placebo. Quote: "All ampoules were identical and packaged in pairs labelled 'pre‐operative' and 'intra‐operative'. Each boxed pair was sequentially coded allowing the study to be carried out in a double‐blind fashion". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Likely blinded from above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Large number of dropouts, although these individuals had been randomized and thus intention‐to‐treat was not followed but the intervention was assigned double‐blinded; the total dropout rate was only 14%, and there were similar numbers of dropouts between the groups (ranging from 10‐23%). Quote: "One hundred and sixty patients agreed to take part in the study. Of these, 23 were withdrawn before induction of anaesthesia. These patients were either not given the study drug or more than 90 min had elapsed between the preoperative injection and the time of arrival in the anaesthetic room". |
Selective reporting (reporting bias) | High risk | Some outcomes not reported or not fully reported |
Other bias | Low risk | Similar baseline characteristics. Unclear role for Selecta UK in trial conduct |