Siddique, R., Hafiz, M.G., Rokeya, B., Jamal, C.Y., & Islam, A. (2011). Ondansetron versus granisetron in the prevention of chemotherapy-induced nausea and vomiting in children with acute lymphoblastic leukemia. Mymensingh Medical Journal, 20(4), 680–688.

Study Purpose

To determine if ondansetron or granisetron is more effective at alleviating chemotherapy-induced nausea and vomiting (CINV) in children with acute lymphoblastic leukemia (ALL)

Intervention Characteristics/Basic Study Process

Children receiving high-dose methotrexate were randomized to receive ondansetron (4 mg) or granisetron (1 mg) orally in 5 ml of water 30 minutes before chemotherapy infusion. Pills were crushed and stored prior to distribution. Patients could receive an additional dose of the drug within 24 hours for moderate vomiting. Patients were assessed at baseline before the infusion and every 24 hours after chemotherapy. Patients did not have any antiemetic drugs in the 24 hours preceding chemotherapy infusion.

Sample Characteristics

  • N = 60
  • AGE: Range = 4 - 11
  • MALES: Not reported
  • FEMALES: Not reported

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Bangladesh

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

RCT, double-blind

Measurement Instruments/Methods

  • Modified Morrow Assessment of Nausea and Emesis (MANE) scale
  • Complete Blood Test (CBC)
  • Serum creatinine
  • Serum alanine aminotransferase (ALT) test

Results

Children in the ondansetron group had a 70% complete response and a 30% partial response to acute CINV (24 hours following infusion). Children in the granisetron group had a 90% complete response and a 10% partial response to acute CINV. There was a significant difference between the group for acute CINV (p < 0.05). Of the children receiving ondansetron, 58.6% had a complete response to delayed CINV and 41.4% had a partial response on day 3, whereas 86.7% in the granisetron group had a complete response and 13.3% had a partial response to delayed CINV on day 3. The difference between groups was significant (p < 0.01). Results on day 4 were similar, with 58.6% of children in the ondansetron group experiencing a complete response and 37.9% experiencing a partial response while 96.7% had a complete response and 3.3% had a partial response in the granisetron group. These results were also significant (p < 0.01). Thirty percent of children receiving ondansetron received additional drug compared to 3.3% in the granisetron group (p < 0.01).

Conclusions

In children with ALL, granisetron is more effective at alleviating both acute and delayed CINV in patients who are on high-dose methotrexate.

Limitations

  • Small sample (< 100)
  • Findings not generalizable
  • Other limitations/explanation: Sample characteristics were not reported. It is unknown if there are group differences.

Nursing Implications

Nurses can advocate for the use of granisetron rather than ondansetron in children who are receiving highly emetic chemotherapy infusions. Granisetron may be more effective for both acute and delayed CINV.