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

Parke 1995.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 77
Country: USA
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: morphine PCA
Pain score collection: blinded investigator
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. Abdominal or vaginal hysterectomy

  2. ASA 1 or 2

  3. Aged 25‐80 years old


Exclusion criteria
  1. Upper gastrointestinal bleed

  2. Renal disease

  3. Intolerance to NSAIDS

  4. Asthma

  5. Psychiatric disease

  6. Malignancy

Interventions Group Pre‐emptive (37 participants): 30 mg ketorolac 30 minutes before incision and saline placebo at skin closure (both 1 mL)
Group Postsurgical (40 participants): saline placebo 30 minutes before incision and 30 mg ketorolac at skin closure (both 1 mL)
Outcomes
  1. Postoperative pain (0‐100 mm VAS at 12 and 24 hours)

  2. Morphine consumption (mg at 24 hours)

Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: no
Other: median and range converted to mean and SD for pain score data (Hozo 2005)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No mention. Quote "Patients were randomised..."
Allocation concealment (selection bias) Unclear risk No mention. Quote "Patients were randomised..."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Identical placebo used and both 1 mL. Quote "...placebo injection at skin closure"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote "...by an investigator who was unaware of the group to which the patient belonged"
Incomplete outcome data (attrition bias)
All outcomes High risk High number of dropouts, more in intervention group including two who were discharged early and therefore likely to have lower pain. Quote "...were discharged before 24 hour follow up"
Selective reporting (reporting bias) Unclear risk No protocol or clinical trial registration
Other bias High risk More vaginal hysterectomies in post‐incision group which on regression analysis were associated with pain as an outcome