| Methods |
Prospective, randomized, non‐blinded (cannot blind waiting versus non waiting) trial. Per power calculations sample size of 196 needed to detect 1cm difference in pain.
Columbia Willamette Planned Parenthood, Portland, Oregon, USA. Study length: May 2000 to June 2001 |
| Participants |
199 pregnant women. Age 18 yrs or older. Gestational age <11wks. Good general health. English language comprehension.
Exclusion criteria: major psychiatric symptoms as well as PID, intravenous sedation or misoprostol. |
| Interventions |
Group 1: 3‐5 minute wait between injection and dilation of the cervix
Group 2: no wait.
All participants: paracervical block (PCB) with total of 12ml 1% buffered lidocaine at 12 (superficially), 4 and 8 o'clock (1‐2cm deep). Diazepam 5mg po and /or fentanyl 100mcg IV as additional pain medication per patient request.
Vacuum aspiration. |
| Outcomes |
Self reported pain and measured with a 10cm visual analog scale with dilation, aspiration and post procedure as well as anticipated pain. Satisfaaction at the end of the procedure (very satisfied, somewhat satisfied, netrual, somewhat dissatisfied, very dissatisfied). |
| Notes |
Per e‐mail communication: randomization with computer generated random numbers in blocks of 50. Allocation concealment with sequentially numbered opaque envelopes.
194 women completed the study and were analysed. 2 excluded for administration of extra sedative medications and 2 lost to follow‐up. One woman chose to discontinue. No major complications reported. Subanalysis per fentanyl use. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
