ondansetron has been researched along with Neonatal Abstinence Syndrome in 3 studies
Ondansetron: A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.
Neonatal Abstinence Syndrome: Fetal and neonatal addiction and withdrawal as a result of the mother's dependence on drugs during pregnancy. Withdrawal or abstinence symptoms develop shortly after birth. Symptoms exhibited are loud, high-pitched crying, sweating, yawning and gastrointestinal disturbances.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Ondansetron is the drug of choice to prevent nausea in women undergoing cesarean surgery and can be used to prevent neonatal abstinence syndrome (NAS)." | 9.20 | Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome. ( Carvalho, B; Clavijo, C; Drover, DR; Elkomy, MH; Galinkin, JL; Peltz, G; Sultan, P; Wu, M, 2015) |
| "Ondansetron is the drug of choice to prevent nausea in women undergoing cesarean surgery and can be used to prevent neonatal abstinence syndrome (NAS)." | 5.20 | Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome. ( Carvalho, B; Clavijo, C; Drover, DR; Elkomy, MH; Galinkin, JL; Peltz, G; Sultan, P; Wu, M, 2015) |
| "Ondansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay." | 3.30 | Ondansetron to reduce neonatal opioid withdrawal severity a randomized clinical trial. ( Adeniyi-Jones, S; Argani, C; Cohane, C; Drover, D; Govindaswami, B; Jansson, LM; Jegatheesan, P; Khan, S; Kraft, WK; Peltz, G; Shafer, S; Wang, M; Wu, M, 2023) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 2 (66.67) | 24.3611 |
| 2020's | 1 (33.33) | 2.80 |
| Authors | Studies |
|---|---|
| Peltz, G | 3 |
| Jansson, LM | 1 |
| Adeniyi-Jones, S | 1 |
| Cohane, C | 1 |
| Drover, D | 1 |
| Shafer, S | 1 |
| Wang, M | 1 |
| Wu, M | 2 |
| Govindaswami, B | 1 |
| Jegatheesan, P | 1 |
| Argani, C | 1 |
| Khan, S | 1 |
| Kraft, WK | 1 |
| Elkomy, MH | 1 |
| Sultan, P | 1 |
| Carvalho, B | 1 |
| Clavijo, C | 1 |
| Galinkin, JL | 1 |
| Drover, DR | 1 |
| Anand, KJ | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| AIM 2- Prevention of Neonatal Abstinence Syndrome[NCT01965704] | Phase 2 | 196 participants (Actual) | Interventional | 2014-09-09 | Completed | ||
| Prevention of Neonatal Abstinence Syndrome[NCT01801475] | Phase 1/Phase 2 | 100 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Number of neonates requiring treatment with phenobarbital or clonidine. (NCT01965704)
Timeframe: 15 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Ondansetron - Neonates | 5 |
| Placebo - Neonates | 5 |
The incidence of neonatal abstinence syndrome (NAS) measured as the number of neonates who need for morphine treatment for the symptoms of neonatal opioid withdrawal syndrome (NOWS) while the neonates received study medication and for the 30 days after stopping the study medication. (NCT01965704)
Timeframe: 35 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Ondansetron - Neonates | 22 |
| Placebo - Neonates | 26 |
Median dose of morphine required by neonates within 15 days of delivery. (NCT01965704)
Timeframe: 15 days
| Intervention | mg (Median) |
|---|---|
| Ondansetron - Neonates | 9.3 |
| Placebo - Neonates | 11.1 |
Severity of NAS will be measured by neonates' length of hospital stay (birth to discharge). Length of stay was calculated with 1) no maximum length, and 2) maximum length of stay capped at 15 days. All participants were included in both analyses. (NCT01965704)
Timeframe: At Day 15 and up to 64 days
| Intervention | days (Mean) | |
|---|---|---|
| Mean hospital stay | Mean hospital stay with a 15-day maximum | |
| Ondansetron - Neonates | 15.5 | 9.3 |
| Placebo - Neonates | 17.4 | 11.2 |
This is a mathematical estimation of the clearance for ondasetron as calculated by NONMEM. (NCT01801475)
Timeframe: 8 hours for women; 48 hours for neonate.
| Intervention | L/hr (Mean) |
|---|---|
| Women - Pregnant/Non-pregnant | 21.8 |
| Neonates | NA |
This is an estimated pharmacokinetic parameter as calculated by NONMEM. (NCT01801475)
Timeframe: 8 hours for women; 48 hours for neonate.
| Intervention | Liters (Mean) |
|---|---|
| Women - Pregnant/Non-pregnant | 27.9 |
| Neonates | NA |
2 trials available for ondansetron and Neonatal Abstinence Syndrome
| Article | Year |
|---|---|
Ondansetron to reduce neonatal opioid withdrawal severity a randomized clinical trial.
Topics: Analgesics, Opioid; Humans; Infant, Newborn; Morphine; Neonatal Abstinence Syndrome; Ondansetron; Ph | 2023 |
Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome.
Topics: Adult; Dose-Response Relationship, Drug; Drug Administration Routes; Drug Administration Schedule; F | 2015 |
1 other study available for ondansetron and Neonatal Abstinence Syndrome
| Article | Year |
|---|---|
Long-Acting Opioids for Treating Neonatal Abstinence Syndrome: A High Price for a Short Stay?
Topics: Analgesics, Opioid; Half-Life; Humans; Infant, Newborn; Length of Stay; Methadone; Morphine; Neonata | 2015 |