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. 2018 May 15;2018(5):CD004829. doi: 10.1002/14651858.CD004829.pub4

Ben‐Shlomo 1999.

Methods Randomisation: random numbers
Allocation concealment: sealed in consecutive envelopes
Blinding of participants/investigators: no
Blinding of assessors: no
No. randomised: 50
No. analysed: 50
Intention‐to‐treat analysis: yes
Power and sample calculations not described
Duration of trial: not stated
Participants Women scheduled for oocyte retrieval
Mean age: 34 years; cause of infertility not reported
Similar baseline characteristics of age, height, and weight
Interventions
  1. Control: conscious sedation and analgesia with IV midazolam 0.06 mg followed after 2 minutes by ketamine 0.75 mg/kg (N = 25)

  2. Intervention: general anaesthesia with IV fentanyl 0.017 mg/kg followed after 2 minutes by IV propofol 2.5 mg/kg (N = 25)


No premedication in either group
Outcomes
  1. Primary: postoperative pain (Likert scale 0 to 3; 0 = none; 3 = severe)

  2. Secondary: clinical pregnancy rate, fertilisation rate, satisfaction (Likert scale 0 to 3)


Other outcomes reported: no. of oocytes retrieved, cleavage rate, arousability, response to painful stimuli
Notes Israel
Single centre
HaEmek Mecical Centre
Funding: not stated
Definition of pregnancy not documented
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers
Allocation concealment (selection bias) Low risk Adequate: sealed envelopes
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Blinding not possible because of the nature of the interventions
Blinding of assessors not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No apparent dropout
Selective reporting (reporting bias) Low risk All pre‐stated outcomes reported
Other bias Unclear risk Comparable baseline characteristics of age, height, and weight but not cause of infertility