METHODS: We enrolled 160 women with hyperemesis gravidarum in a double-blind randomized trial. Participants were randomized to intravenous 4 mg ondansetron or 10 mg metoclopramide every 8 hours for 24 hours. Participants kept an emesis diary for 24 hours; at 24 hours, they expressed their well-being using a 10-point visual numeric rating scale and answered an adverse effects questionnaire. Nausea intensity was evaluated using a 10-point visual numeric rating scale at enrollment and at 8, 16, and 24 hours. Primary analysis was on an intention-to-treat basis.
RESULTS: Eighty women each were randomized to ondansetron or metoclopramide. Median well-being visual numeric rating scale scores were 9 (range, 5-10) compared with 9 (range, 4-10) (P=.33) and vomiting episodes in the first 24 hours were 1 (range, 0-9) compared with 2 (range, 0-23) (P=.38) for ondansetron compared with metoclopramide, respectively. Repeat-measures analysis of variance of nausea visual numeric rating scale showed no difference between study drugs (P=.22). Reported rates of drowsiness (12.5% compared with 30%; P=.01; number needed to treat to benefit, 6), xerostomia (10.0% compared with 23.8%; Pondansetron. Length of hospital stay was similar.
CONCLUSION: Ondansetron and metoclopramide demonstrated similar antiemetic and antinauseant effects in hyperemesis gravidarum. However, the overall profile, particularly regarding adverse effects, was better with ondansetron. In our setting, metoclopramide was significantly less expensive than ondansetron and remained a reasonable antiemetic choice.
CLINICAL TRIAL REGISTRATION: ISRCN Register, www.isrctn.org, ISRCTN00592566.
LEVEL OF EVIDENCE: I.
RECENT FINDINGS: The cause of hyperemesis is continuing to be elaborated. Recent data attest to the effectiveness of the oral doxylamine-pyridoxine in NVP. Follow-up data of children exposed in early pregnancy to doxylamine-pyridoxine for NVP are reassuring. Evidence is increasing for ginger as an effective herbal remedy for NVP. Metoclopramide is effective in NVP and hyperemesis gravidarum, with a good balance of efficacy and tolerability. A recent large-scale study on first trimester exposure to metoclopramide is reassuring of its safety. Evidence is emerging for the treatment of acid reflux to ameliorate NVP. The role of corticosteroids for hyperemesis gravidarum remains controversial. Transpyloric feeding may be warranted for persistent weight loss, despite optimal antiemetic therapy.
SUMMARY: Women with significant NVP should be identified so that they can be safely and effectively treated.
AIMS: To investigate the effect of intraperitoneal administration of ondansetron for postoperative pain management as an adjuvant to intravenous acetaminophen in patients undergoing laparoscopic cholecystectomy.
METHODS: Patients scheduled for elective laparoscopic cholecystectomy were randomized into two groups (n = 25 each) to receive either intraperitoneal ondansetron or saline injected in the gall bladder bed at the end of the procedure. The primary outcome was the difference in pain from baseline to 24-h post-operative assessed by comparing the area under the curve of visual analog score between the two groups.
RESULTS: The derived area under response curve of visual analog scores in the ondansetron group (735.8 ± 418.3) was 33.97% lower than (p = 0.005) that calculated for the control group (1114.4 ± 423.9). The need for rescue analgesia was significantly lower in the ondansetron (16%) versus in the control group (54.17%) (p = 0.005), indicating better pain control. The correlation between the time for unassisted mobilization and the area under response curve of visual analog scores signified the positive analgesic influence of ondansetron (rs =0.315, p = 0.028). The frequency of nausea and vomiting was significantly lower in patients who received ondansetron than that reported in the control group (p = 0.023 (8 h), and 0.016 (24 h) respectively).
CONCLUSIONS: The added positive impact of ondansetron on postoperative pain control alongside its anti-emetic effect made it a unique novel option for patients undergoing laparoscopic cholecystectomy.