Skip to main content
. 2021 Jun 14;2021(6):CD012978. doi: 10.1002/14651858.CD012978.pub2

Colbert 1998.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 77
Country: Ireland
Setting: secondary care
Dates conducted: July 1996 to December 1996
Postoperative opioid used and delivery: IM pethidine
Pain score collection: blinded investigator
Concurrent postoperative analgesics: diclofenac or paracetamol
Participants Inclusion criteria
  1. ASA 1 or 2

  2. Breast biopsy


Exclusion criteria
  1. Contraindications to NSAID use

  2. Fine wire localised breast biopsy

Interventions Group A (37 participants): 20 mg IV tenoxicam 30 minutes before surgery
Group B (40 participants): 20 mg IV tenoxicam post‐incision
Outcomes
  1. Postoperative pain (0‐100 mm VAS at 30, 60, 120 and 240 minutes after surgery)

  2. Time to analgesic request (minutes)

  3. Analgesic consumption (paracetamol, diclofenac and pethidine in the first 4 hours postoperatively)

Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: no
Other: analgesic consumption not included as at 4 hours. Included as a pre‐emptive intervention as not all participants received diclofenac postoperatively
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Table of random numbers. Quote: "table of random numbers"
Allocation concealment (selection bias) Unclear risk No mention
Blinding of participants and personnel (performance bias)
All outcomes High risk No double‐dummy placebo. Quote: "The patients in group A received 20 mg tenoxicam IV 30 mins pre‐operatively and patients in group B received 20 mg tenoxicam IV post‐incision".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote: "outcomes were assessed by an investigator without knowledge of the timing of tenoxicam administration".
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants analysed. Quote: "There were 37 patients in group A (20 mg tenoxicam and 30 min before surgery) and 40 patients in group B (20 mg tenoxicam post‐incision)".
Selective reporting (reporting bias) Unclear risk No protocol or trial registration
Other bias Low risk Similar baseline characteristics. Quote: "There were no differences between the groups with respect to age, duration of surgery, length of the wound or the weight of the patient".