Effect of Parecoxib on Post-craniotomy Pain
Condition: Anaesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of this trial:

      To investigate whether post-craniotomy analgesia with (i) intravenous (IV) parecoxib plus
      intravenous paracetamol is superior to (ii) intravenous paracetamol alone.

      Study Hypothesis:

      Post-operative analgesia with intravenous parecoxib in combination with intravenous
      paracetamol will be superior to intravenous paracetamol alone.
    

Detailed description: 
      Neurosurgical patients undergoing brain procedures (craniotomy patients) are known to suffer
      moderately severe postoperative pain and high rates of post-operative nausea and vomiting.
      Post-craniotomy pain is poorly treated with more than 50% of craniotomy patients experiencing
      postoperative pain of moderate or severe intensity. Fear of drug complications such as
      sedation, respiratory depression, seizures and intracranial bleeding has inhibited
      prescribing of effective pain treatment.Non-steroidal anti-inflammatory drugs (NSAIDS) are
      known to be effective analgesics in the peri-operative period however there use in cranial
      neurosurgery has been limited due to risk of bleeding. Parecoxib is an injectable form of
      NSAID that works through inhibiting cyclo-oxygenase type-2 (COX-2). The main benefit of COX-2
      inhibitors is that they have minimal inhibition of platelet function and therefore minimal
      risk of increased bleeding.This project aims to evaluate whether parecoxib is an effective
      pain reliever (analgesic) after brain surgery. Patients aged 18-65 years presenting for
      elective craniotomy will be randomly allocated to two different analgesic programs (i) IV
      parecoxib and IV paracetamol or (ii) IV paracetamol. All patients will receive a standardised
      anaesthetic. Scalp infiltration, using 20mls of local anesthetic (bupivacaine 0.5% with
      adrenaline), will occur prior to skin incision. Intermittent morphine administration will
      used post-operatively to ensure adequate analgesia in each arm of the trial. Immediate
      post-operative adjunctive analgesia will be provided with nurse administered IV morphine in
      the post-anaesthetic care unit (PACU) as per protocol (RMH protocol for opioid titration),
      followed by patient controlled analgesia (PCA) morphine once the verbal rating scale is < 4
      (rating out of ten). A score of less than four is considered to be mild pain. PCA will be
      continued for the first twenty-four hours then discontinued. Patients will then receive
      strict oral paracetamol and nurse administered IV morphine as required. The primary study
      endpoint will be morphine consumption in the first 24 hours. Data will be analysed on an
      intention to treat basis. Continuous variables will be graphed to determine their
      distribution. Normally distributed variables will be described using mean and standard
      deviation and compared using Student's t-tests. Skewed variables will be described using
      median and range (or interquartile range) and compared using Wilcoxon rank sum tests. A
      p-value les than 0.05 will be considered statistically significant.
    

Intervention name(s): Intravenous Parecoxib ('Dynastat' Pfizer)
Intervention type(s): Drug
Intervention description(s): parecoxib or placebo
Other intervention name(s): Intravenous parecoxib ("Dynastat" Pfizer)
Intervention MeSH terms: Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesia; pain; neurosurgery; NSAIDS; parecoxib; morphine consumption