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. 2021 Jun 14;2021(6):CD012978. doi: 10.1002/14651858.CD012978.pub2

Rogers 1995.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 58
Country: UK
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: diamorphine PCA
Pain score collection: not collected
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. Abdominal hysterectomy by transverse lower abdominal incision


Exclusion criteria
  1. ASA 3 or 4

  2. < 45 kg or > 90 kg in weight

  3. Malignancy

  4. Endometriosis

  5. Alcohol or drug addiction

  6. Chronic analgesic use

  7. Contraindication to ketorolac

Interventions Group Ketorolac before operation (30 participants): 10 mg IV ketorolac between induction and skin incision and saline placebo between closure of skin and recovery
Group Ketorolac after operation (28 participants): saline placebo between induction and skin incision and 10 mg IV ketorolac between closure of skin and recovery
Outcomes
  1. Diamorphine consumption (mg at 2, 4 and 12 hours)

  2. Opioid adverse events (nausea, vomiting, anti‐emetic use and pruritus at 12 hours)

  3. Intraoperative blood loss (in a standard way by weighing swabs and measuring the volume of suction loss intraoperatively)

Notes Funding: no mention
Declarations of interest: no mention
Authors contacted: no
Other: anti‐emetic used for nausea and vomiting. No events for pruritus so data not entered
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated. Quote: "...computer‐generated random numbers in blocks of 12"
Allocation concealment (selection bias) Low risk Pharmacy‐controlled. Quote: "The hospital pharmacy prepared.."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo used. Quote: "...containing either 0.9% normal saline 51 ml alone or 0.9% normal saline 50 ml with ketorolac 10 mg (1 ml). They were labelled with a code held by the pharmacy until the end of the study. Each patient was given one infusion between induction of anaesthesia and skin incision, and another between skin closure and arrival in the recovery ward".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Likely blinded from above
Incomplete outcome data (attrition bias)
All outcomes High risk Thirteen participants excluded. Quote: "...13 patients were later withdrawn; seven because a different operative procedure was performed, three because endometriosis was diagnosed at operation and three because of administrative errors in the conduct of the study".
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Low risk Similar baseline characteristics