OBJECTIVE: To compare evacuation under systemic analgesia (fentanyl and midazolam) in a treatment room (ward group) with evacuation under general anaesthesia in theatre. DESIGN: A prospective randomised clinical trial. SETTING:A tertiary medical centre serving a black urban population. SUBJECTS:One hundred and forty-two patients with uncomplicated incomplete abortions. INTERVENTION: Randomisation into two groups, those for evacuation under systemic analgesia and those for evacuation under general anaesthesia. MAIN OUTCOME MEASURES: Both groups were compared in terms of safety, efficacy, acceptability, blood consumption and time delay between admission and evacuation. RESULTS: Significantly less blood was used in the ward group (37 units for 13 patients) than in the theatre group (65 units for 24 patients) (P < 0.03). Significantly less time was taken between admission and evacuation in the ward group (median 7 hours 15 minutes) than in the theatre group (median 12 hours 38 minutes) (P < 0.0003). Evacuation under fentanyl and midazolam was safe, effective and acceptable for the majority of patients compared with evacuation under general anaesthesia. CONCLUSION:Patients with uncomplicated incomplete abortions (uterine size equivalent to a pregnancy of 14 weeks' duration or less) can undergo evacuation safely and effectively under fentanyl and midazolam and have a significantly smaller chance of requiring a blood transfusion.
RCT Entities:
OBJECTIVE: To compare evacuation under systemic analgesia (fentanyl and midazolam) in a treatment room (ward group) with evacuation under general anaesthesia in theatre. DESIGN: A prospective randomised clinical trial. SETTING: A tertiary medical centre serving a black urban population. SUBJECTS: One hundred and forty-two patients with uncomplicated incomplete abortions. INTERVENTION: Randomisation into two groups, those for evacuation under systemic analgesia and those for evacuation under general anaesthesia. MAIN OUTCOME MEASURES: Both groups were compared in terms of safety, efficacy, acceptability, blood consumption and time delay between admission and evacuation. RESULTS: Significantly less blood was used in the ward group (37 units for 13 patients) than in the theatre group (65 units for 24 patients) (P < 0.03). Significantly less time was taken between admission and evacuation in the ward group (median 7 hours 15 minutes) than in the theatre group (median 12 hours 38 minutes) (P < 0.0003). Evacuation under fentanyl and midazolam was safe, effective and acceptable for the majority of patients compared with evacuation under general anaesthesia. CONCLUSION:Patients with uncomplicated incomplete abortions (uterine size equivalent to a pregnancy of 14 weeks' duration or less) can undergo evacuation safely and effectively under fentanyl and midazolam and have a significantly smaller chance of requiring a blood transfusion.
Authors: Vanessa K Dalton; Lisa H Harris; Katherine J Gold; Lisa Kane-Low; Jay Schulkin; Ken Guire; A Mark Fendrick Journal: Am J Obstet Gynecol Date: 2010-03-15 Impact factor: 8.661