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

Lok 2002.

Methods Randomisation: computer‐generated
Allocation concealment: sealed opaque envelopes
Blinding of participants/investigators: no
Blinding of assessors: no
No. randomised: 110
No. analysed: 106
Intention‐to‐treat analysis: no
Power and sample calculations described
Duration of trial: not stated
Participants Women undergoing transvaginal oocyte retrieval
Mean age: 33 to 35 years
Cause of infertility: tubal disease, male factor, endometriosis, anovulation, unexplained
Women in control group 2 years younger than women in intervention group (P = 0.01); other baseline characteristics similar
Interventions
  1. Control: patient‐controlled sedation and analgesia (IV propofol 10 mg/mL and alfentanil 40 mcg/mL) via a pump (N = 51)

  2. Intervention: physician‐administered sedation and analgesia with IV pethidine 1.5 mg/kg 5 to 10 minutes before oocyte retrieval (N = 55); additional pethidine 0.5 mg/kg given when necessary


No premedication in either group
Outcomes
  1. Primary: intraoperative and postoperative pain scores (VAS 0 to 100)

  2. Secondary: fertilisation, clinical pregnancy rate, patient satisfaction (VAS)

Notes China
Single centre
Chinese University of Hong Kong
Funding: not stated
Loss to follow‐up (N = 4) in intervention group due to pump failure (n = 1) and personal reasons (n = 3)
Definition of pregnancy not documented
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated
Allocation concealment (selection bias) Low risk Adequate: sealed envelopes
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Blinding not possible owing to the nature of the interventions
Blinding of assessors not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Four lost to follow‐up (3%)
Selective reporting (reporting bias) Low risk All prespecified outcomes reported
Other bias Unclear risk Significant differences in age between the 2 groups
Comparable infertility characteristics at baseline