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. 2019 Nov 21;2019(11):CD011931. doi: 10.1002/14651858.CD011931.pub2

Misra 2013.

Methods Study design: randomized controlled trial (2 arms)
Study duration: not reported
Study setting: hospital, single centre, India
Participants Adults undergoing elective craniotomy for tumour resection who were receiving preoperative intravenous (IV) dexamethasone for at least 48 hours (n = 79)
Inclusion criteria
  1. Adults undergoing above surgery


Exclusion criteria
  1. Pregnancy

  2. Breast feeding

  3. Patients on preoperative anti‐emetic, gabapentin or pregabalin

  4. Patients with an allergy to any study drug

  5. Renal dysfunction

  6. Significant nausea or vomiting preoperatively

  7. Emergency craniotomy


Mean age, range (years)
  1. 39 (18 to 60)


Numbers allocated to each arm
  1. Group intervention (n = 39)

  2. Group control (n = 40)


Male gender
  1. Group intervention: 20/36 (participants analysed)

  2. Group control: 20/37 (participants analysed)

Interventions Technique and timing
  1. Gabapentin 600 mg orally, given 2 hours before surgery versus vitamin B placebo given at the same time point


Dosage
600 mg
Outcomes Primary
  1. Incidence of nausea and vomiting in the first 24 hours after surgery


Secondary
  1. Postoperative pain scores as measured on a scale of 0 to 3

  2. Incidence of moderate/severe pain

  3. Intraopertive anaesthetic requirement

  4. Postoperative narcotic consumption

  5. Postoperative nausea and vomiting

Notes Funding
None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: ''randomisation was done by means of a computer‐generated random number scheme.'' Patients were allocated to receive either placebo (vitamin B‐complex capsule) (group D) or 600 mg of gabapentin (group GD), administered orally, 2 hours before the induction of anaesthesia by means of a sealed envelope.
Allocation concealment (selection bias) Low risk Quote: ''patients were allocated to receive either placebo (vitamin B‐complex capsule) (group D) or 600 mg of gabapentin (group GD), administered orally, 2 hours before the induction of anaesthesia by means of a sealed envelope''.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Placebo tablets were used to blind participants.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 6 participants were lost to follow‐up: 3 in each group due to delayed extubation. An intention‐to‐treat analysis was not used.
Selective reporting (reporting bias) Low risk Outcomes reported as specified
Other bias High risk Small study and no sample size calculation provided