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

Peduto 1995.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 30
Country: Italy
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: none
Pain score collection: blinded independent observer
Concurrent postoperative analgesics: none
Participants Inclusion criteria
  1. Elective septoplasty

  2. ASA 1 or 2

  3. Aged 18‐45 years old


Exclusion criteria
  1. Long‐term NSAIDs or other analgesics

  2. Steroid treatment

  3. Lithium

  4. Aminoglycosides

  5. Oral hypoglycaemics

  6. Antihypertensives or diuretics

  7. Peptic ulcer

  8. Bleeding

  9. G6PD deficiency

  10. Liver or renal disease

  11. Asthma/COPD

Interventions Group I (15 participants): IV ketorolac 4 mg/kg 10 minutes before induction and saline placebo 5 minutes after incision
Group II (15 participants): IV ketorolac 4 mg/kg 5 minutes after incision and placebo 10 minutes before induction
Outcomes
  1. Postoperative pain (0‐10 cm VAS and 11‐point scale at 60, 90, 120, 150 and 180 minutes postoperatively)

  2. Blood pressure and heart rate (mmHg and beats per minute at 60, 90, 120, 150 and 180 minutes postoperatively)

  3. Adverse events (composite of skin reactions, nausea, vomiting, shivering, headache and bleeding during follow‐up)

Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: no
Other: pain data extracted from graph and SD estimated. Side effects not included as composite
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details. Quote: "Patients were randomly divided into two groups".
Allocation concealment (selection bias) Unclear risk No details. Quote: "Patients were randomly divided into two groups".
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo. Quote: "...in the other...30 min before surgery, placebo (physiological solution of volume equal to 0.4 mg / kg of ketorolac) 10 min before intervention"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote: "An independent observer, in the dark of the type of treatment performed"
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No mention
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Low risk Similar baseline characteristics. Quote: "No differences were found significant between the two groups as far as concerns anthropometric data (weight, height age, sex, age) and the duration of the intervention (average 37 min, with a minimum of 23 min and a maximum of 51 min)".