pain relief during labour. Spontaneous vertex delivery
Conditions
Interventions
Intervention 1: Intervention group: a bolus dose of remifentanil 25 mg and continous infusion of 0.06 µg/kg/min remifentanil and 0.5 mg/kg/h ketamine for 4 hours (maximum dose of ketamine 2mg/kg) via
Treatment - Drugs
Intervention group: a bolus dose of remifentanil 25 mg and continous infusion of 0.06 µg/kg/min remifentanil and 0.5 mg/kg/h ketamine for 4 hours (maximum dose of ketamine 2mg/kg) via pump. After four
Control group: a bolus dose of remifentanil 25 mg and continous infusion of 0.06 mg/kg/min remifentanil.
Sponsors
Arash Women's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: nulliparous, ASA I, II, gestational age 38-42 weeks in early labour Exclusion criteria: weight less than 50 kg more than 100 kg, candidate to undergo epidural analgesia, multifetus pregnancy, pre-eclampsia, premature labour, allergy to any agent under investigation, history of alcohol or drug abuse, psychiatric disorder
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief during labor. Timepoint: from active labor phase (cervical dilation 4-5 cm) until labour. Method of measurement: VAS score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate. Timepoint: every 30 minutes. Method of measurement: pulse-oximetry.;SPO2. Timepoint: every 30 minutes. Method of measurement: pulse-oximetry.;Respiratory rate. Timepoint: every 30 minutes. Method of measurement: visual monitoring.;Fetal heart rate. Timepoint: every 30 minutes. Method of measurement: surface ultrasound.;Present or absent of nausea and vomiting. Timepoint: every time is peresent. Method of measurement: visual monitoring and patient's saying.;Overall effective analgesia. Timepoint: every 30 minutes after statring analgesia. Method of measurement: VAS score.;Arterial pressure. Timepoint: every 30 minutes after statrting analgesia. Method of measurement: non-invasive arterial presssure monitoring. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Ashraf Moini
Tehran University of Medical Sciences
Outcome results
None listed