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

Fletcher 1995.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 40
Country: France
Setting: secondary care
Dates conducted: not reported
Postoperative opioid used and delivery: IV bolus then PCA morphine
Pain score collection: blinded investigator
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. ASA 1 or 2

  2. Elective total hip replacement


Exclusion criteria
  1. Contraindications to NSAIDs

  2. Aged younger than 18 years or older than 85 years

  3. ASA > 3

  4. Any type of surgery other than THR

  5. Regional anaesthesia

  6. Any condition precluding the limitation of intraoperative fentanyl administration

  7. Contraindications to the self‐administration of opioids

  8. Past history of drug abuse

  9. Severe respiratory insufficiency

  10. Long duration of surgery (more than 4 hours)

  11. Cumulative intraoperative dose of fentanyl higher than 4 mcg/kg

  12. A second operation within 48 hours

  13. Severe respiratory depression after surgery or administration of naloxone

  14. Difficulty in using the PCA device

  15. Use of analgesic drugs other than morphine

Interventions Group PRE (20 participants): 60 mg IV ketorolac before induction and then 2 mL IV normal saline at the end of surgery
Group POST (20 participants): 2 mL IV normal saline before induction and then 60 mg IV ketorolac at the end of surgery
Outcomes
  1. Morphine consumption (mg consumed every 12 hours for 48 hours)

  2. Postoperative pain at rest and on movement (0‐10 cm VAS in the recovery room and at 1, 2, 3, 4, 5, 6 hours and every 6 hours for 48 hours)

  3. Adverse events (nausea and vomiting, pruritus, urinary retention, blood loss, number of transfusions, sedation, respiratory depression during study follow‐up)

Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: no
Other: some pain score and morphine consumption data extracted from graph
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table. Quote: "a random‐number table was used to generate a randomized schedule specifying the group to which each patient would be assigned upon entry into the trial".
Allocation concealment (selection bias) Unclear risk No mention
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo. Identical in appearance. Quote: "The pre‐operative KET group (PRE; n = 20) received 60 mg of KET and then 2 ml of NS".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote: "all patients and personnel involved in patient management and data collection were unaware of the group to which the patient had been assigned".
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants analysed
Selective reporting (reporting bias) High risk Some adverse events not reported
Other bias High risk More females in POST group (Gerbershagen 2014)