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

Moonla 2018.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 84
Country: Thailand
Setting: secondary care hospital
Dates conducted: February 2016 to May 2017
Postoperative opioid used and delivery: PCA morphine
Pain score collection: not reported
Concurrent postoperative analgesics: none
Participants Inclusion criteria
  1. Aged 21–88 years old

  2. Not pregnant or lactating

  3. Fully conscious and able to agree with the study protocol

  4. Major spinal surgery (expected to be a long surgery) involving > 2 spinal levels or using spinal fixation devices

  5. Attended by a neurosurgeon with > 3 years experience in spinal surgery

  6. ASA 1‐3


Exclusion criteria
  1. < 50 kg

  2. Receiving any analgesic drug within 24 hours prior to surgery

  3. Liver impairment

  4. Renal impairment or signs of fluid retention

  5. Fluconazole within 1 week prior to surgery

  6. Hypersensitivity to parecoxib, sulfonamides, or other NSAIDs, including compounds contained in parecoxib

  7. Contraindication to parecoxib administration

  8. Contraindication to lorazepam use, anesthesia medications, and morphine

Interventions Group Pre (42 participants): 40 mg parecoxib before skin incision and at 12 and 24 hours after the first dose
Group Post (42 participants): 40 mg parecoxib at wound closure and at 12 and 24 hours after the first dose
Outcomes
  1. Postoperative pain (0‐10 cm VAS every 2 hours for the first 8 hours after surgery and then every 4 hours for the next 16 hours thereafter)

  2. Morphine consumption (mg in 24 hours)

  3. Time to analgesia (not reported)

  4. Adverse events (nausea and vomiting, abdominal pain, flatulence, limb oedema, dizziness, drowsiness, and oliguria at 24 hours)

Notes Funding: none reported
Declarations of interest: "No potential conflict of interest relevant to this article was reported".
Authors contacted: no
Other: data taken from graphs and SD calculated from SEM
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomization. Quote: "...block randomization sampling method"
Allocation concealment (selection bias) Unclear risk No mention
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo. Quote: "This study was a double‐blind trial. Each group received six doses of intravenous solution. All solutions were colorless, and each solution was given in a 2 mL volume, prepared by a nurse anesthetist who was not involved in the assessment and patient care before, during, and after operation".
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention
Incomplete outcome data (attrition bias)
All outcomes High risk Large number of dropouts. Quote: "Because of incomplete data, 17 of 144 patients were excluded from the study; nine patients withdrew consent, five had surgical complications that required intervention, and three required prolonged postoperative mechanical ventilation".
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Low risk Similar groups