Fertility-female
Conditions
Interventions
Melatonin
Placebo
Sponsors
Ikpodaupade Remigius Kofa
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Pregnant women scheduled for elective caesarean section at term
Exclusion criteria
Exclusion criteria: Pregnant women who are allergic to melatonin. Pregnant women who used narcotic painkillers within the 24 hours period before caesarean section. Pregnant women who abuse alcohol or drug. Pregnant women on long-term antidepressant or analgesic drug(s). Pregnant women with history of chronic headache, significant hepatorenal disorders, ischaemic heart disease, seizures, uncontrolled hypertension and uncontrolled type 2 diabetes mellitus, preeclampsia, eclampsia, psychiatric disorders, sleep disorders, organ transplantation and patients on anticoagulants. Pregnant women with any contraindication to regional anaesthesia such as local infection or bleeding disorders. Pregnant women undergoing third repeat caesarean section and above (risk of prolonged surgery). Pregnant women with a history of previous uterine rupture (uterotonic effect of melatonin with theoretical risk of uterine rupture).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity measured at 2, 6, 12 and 24 hours post-operation using the NRS for pain. Time interval to first postoperative requirement of opioid analgesia. The amount of opioid analgesic consumed in the first postoperative 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time interval to resumption of ambulation after caesarean section. Incidence of side effects including nausea, vomiting, pruritus and headache. Apgar score of the neonate at the first and fifth minutes of life. | — |
Countries
Nigeria
Contacts
Public ContactWaripamo Petre Oweisi
Consultant
Outcome results
None listed