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

Vijayendra 1998.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 40
Country: India
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: not reported
Pain score collection: not reported
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria

  1. ASA 1 or 2

  2. Male or female

  3. Removal of orthopaedic implant < 90 minutes


Exclusion criteria

  1. Renal disease

  2. Hepatic disease

  3. Bleeding disorders

  4. Peptic ulcer disease

  5. Sensitivity to NSAIDs

  6. Anticoagulants
Interventions Group I (20 participants): IV 60 mg ketorolac just before induction and saline placebo at the end of surgery
Group II (20 participants): IV 60 mg ketorolac at the end of surgery and saline placebo before induction
Outcomes

  1. Postoperative pain (0‐10 cm VAS at 0, 1, 2, 4, 6, 12 and 24 hours)

  2. Morphine consumption (mg consumed at 24 hours)

  3. Bleeding time (minutes at 2, 4, 6 hours)

  4. Time to analgesic request (minutes)
Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: no
Other: pain score data taken from graph and SD estimated from other studies. Early acute postoperative pain taken from one hour to allow post‐incision dose to be effective
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No mention. Quote: "...the patients were divided".
Allocation concealment (selection bias) Unclear risk No mention. Quote: "...the patients were divided".
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo used. Quote: "Group I received 60 mg ketorolac...and 5cc of normal saline at the end of surgery".
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants analysed
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Low risk Similar baseline characteristics. Quote: "The two groups were comparable..."