| Methods |
Randomized controlled trial. Randomization with computerized, random number generation carried out outside the familiy planning unit. Per power analysis 33 patients per group required.
Cumhuriyet University, School of Medicine, Sivas, Turkey. Study length: May 1996 to November 1996. |
| Participants |
66 pregnant women. Singleton intrauterine pregnancy at 6‐11 weeks of gestational age by LMP confirmed bv transvaginal ultrasound. |
| Interventions |
Group 1: deep injection (superficially 1ml, 3ml 3cm deep at 4, 6, 8, and 10 o'clock position; total of 16ml) of PCB
Group 2: regular injection (1.5cm deep at same 4 positions) of 10ml 1% lidocaine local anesthetic for paracervical block.
All participants: 5mg oral diazepam 60 minutes prior to procedure if preprocedural anxiety of 6 or more (rated by physician not performing procedure). After 2 minute wait, cervical dilation.
Vacuum aspiration followed by sharp curette. |
| Outcomes |
Pain associated with dilation and curettage was rated by patient on a verbal analog scale of 0 to 10 (0 = no pain, 10 = severe pain) after the procedure.
Anxiety score, procedure time, basal cervical dilation and dilation increased obtained. Follow‐up visit 4‐6weeks after the procedure to assess late complications and to perform a gynecological exam. |
| Notes |
Physician not performing procedure rated preprocedural anxiety (scale 1‐10). Otherwise blinding is not commented on. Unclear how many got diazepam and in which group they were.
The author could not be succeessfully contacted to clarify unclear information.
No adverse effects, no major complications. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
