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

Priya 2002.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 50
Country: India
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: IV tramadol
Pain score collection: blinded investigator
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. ASA 1 or 2

  2. Elective breast surgery such as lumpectomy, simple mastectomy and modified radical mastectomy


Exclusion criteria
  1. Less than 18 years or more than 65 years of age

  2. Allergy to any NSAID

  3. Renal disease

  4. Asthma

  5. Coagulopathy

  6. Peptic ulcer disease

Interventions Group I (25 participants): 100 mg IV ketoprofen 30 minutes before incision and saline immediately after incision
Group II (25 participants): 100 mg IV ketoprofen immediately after incision and saline placebo 30 minutes before incision
Outcomes
  1. Postoperative pain (0‐10 cm VAS at 1, 1.5, 2, 4, 6, 8, 10, 12, 14, 16, 18 and 20 hours postoperatively)

  2. Time to analgesia (hours)

  3. Number of analgesics (number during follow‐up)

  4. PONV (1‐5 scale during follow‐up, number with a score of 5 (nausea and vomiting) included in analysis)

Notes Funding: "None"
Declarations of interest: "None"
Authors contacted: no
Other: time to analgesia reported as time‐to‐event but not enough information to extract data
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated. Quote: "...computer‐generated table of random numbers"
Allocation concealment (selection bias) Unclear risk No details
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo. Quote: "This infusion was completed 30 minutes before the surgical incision was taken. 100 ml plain normal saline was infused over 15 minutes immediately after surgical incision in this group".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote: "...were recorded by an independent, blinded observer"
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants completed study.
Selective reporting (reporting bias) Unclear risk No protocol
Other bias High risk Participants excluded from pain scores once received analgesia