Hall 1997.
| Methods | Randomized trial. Outpatient clinic of the Department of Obstetrics and Gynecology at the Karolinska Hospital in Stockholm, Sweden. No power calculation. | |
| Participants | 200 pregnant women. Age: older than 18. Outpatient clinic, legal 1st trimester surgical abortion. | |
| Interventions | Group 1: preoperative vaginal prostaglandin (PG) (PGE1, gemeprost 1mg given vaginally 3hrs preoperatively) for cervical softening, surgery in general anesthesia (GA) Group 2: preoperative PG and surgery in GA and paracervical block (PCB, 10 and 10ml lidocaine 10mg/ml) Group 3: surgery in GA Group 4: GA and PCB. Premedication with morphine 5‐10mg IM 60‐90 minutes preoperatively. GA with propofol 2mg/kg IV, 60% nitrous oxide in oxygen, breathed spontaneously by mask and isoflurane supplementation as needed. Dilation of the cervix as needed followed by vacuum suction curettage and 10IU oxytocin IV. Postoperatively oral medications per patient request: paracetamol 500mg and codeine phosphate 30mg for pain or thiethylperazin 6.5mg for nausea. |
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| Outcomes | Pain preoperatively, and postoperatively (at 1, 2, 3 and 4 hrs); consumption of analgesics postoperatively; nausea; time interval to discharge home. Study instrument: Visual analog scale (VAS; 10cm from "no pain" to "worst pain ever"; no nausea to extreme nausea) for pain and nausea. | |
| Notes | Per e‐mail communication with Dr. Persson, the coauthor, the study length was 4 months. Patients were randomized and allocation concealment was with closed envelopes. All investigators were blinded; not the operating gynecologist and not the nurses . Women in the two groups receiving PG were significantly younger, of lower gravity and parity than women in the two groups not receiving PG. The discussion does not include this being a possible confounder of the lower pain perception and analgesia need in the latter two groups. No major complications reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |