]>
IRCT2017082935979N1 IRCT 2017-11-14 Vice chancellor for research in Qazvin university of medical sciences Comparing the analgesic effect of intrathecal Sufentanil with intravenous Acetaminophen in combination with low-dose Ketamine on labor pain NO Comparing the analgesic effect of intrathecal Sufentanil with intravenous Acetaminophen in combination with low-dose ketamine onl abor pain 2017-04-21 anticipated 120 Complete https://irct.ir/trial/27032 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Analgesia in Labour. Intervention 1: Intervention group :1000 mg of intravenous acetaminophen in 100 ml of normal saline will be injected intravenously in 15 minutes with 0.03 mg / kg of ketamine, and the maintenance dose of ketamine is dosed at a rate of 0.3 mg / kg / hour after 30 minutes from the initial dose and after completing the dilatation or in the event of sleepiness and failure to respond to the simple instructions, it's discontinued. Intervention 2: Control group: Spinal anesthesia will be performed in sitting position by needle number 25 and through inter-vertebral spaces of L3-L4 or L4-L5. 5 μg of sufentanil (1 ml) will be used for spinal anesthesia. Immediately after spinal anesthesia, the pregnant woman will be placed in the back and horizontal position, and she is in this situation for 5 minutes.
public Mona Koochak Pour
Kosar Medical Education Center,Taleghani Street,Qazvin
Qazvin Iran (Islamic Republic of) +98 28 3323 6375 Mon_470@yahoo.com Qazvin University Of Medical Sciense scientific Mona Koochak Pour
Kosar Medical Education Center,Taleghani Street, Qazvin
Qazvin Iran (Islamic Republic of) +98 28 3323 6375 mon_470@yahoo.com Qazvin University Medical Sceinces Iran (Islamic Republic of) Inclusion criteria are as follows: o Pregnant women who are candidates for natural delivery and are in the active phase (Cervical dilatation of 5-3 cm); o Pregnant women with no history of physical and psychological illness or biochemical abnormalities (ASA I class); o Pregnant women who have written and complete consent for the study. Exclusion criteria are as follows: o Dissatisfaction pregnant women; o Mother's preeclampsia and eclampsia; o Insulin-dependent diabetes; o Mother drug abuse history; o Using any analgesic method before entering the study; o History of liver disease; o History or presence of bleeding disorder and coagulation disorders in the mother; o using anticoagulant drugs; o History of mental illness or using antidepressants or anticonvulsants; o Any contraindication for spinal anesthesia; o History of allergic reactions or intolerant to the drugs studied (Sufentanil, acetaminophen and ketamine); o Any significant or severe systemic disease that limits usual and natural activities (such as kidney disease that require dialysis, class 2 heart failure and ….). no limit no limit Female O74 Maternal complications arising from the administration of a general or local anaesthetic, analgesic or other sedation during labour and delivery Treatment - Drugs Treatment - Drugs Intervention group :1000 mg of intravenous acetaminophen in 100 ml of normal saline will be injected intravenously in 15 minutes with 0.03 mg / kg of ketamine, and the maintenance dose of ketamine is dosed at a rate of 0.3 mg / kg / hour after 30 minutes from the initial dose and after completing the dilatation or in the event of sleepiness and failure to respond to the simple instructions, it's discontinued. Control group: Spinal anesthesia will be performed in sitting position by needle number 25 and through inter-vertebral spaces of L3-L4 or L4-L5. 5 μg of sufentanil (1 ml) will be used for spinal anesthesia. Immediately after spinal anesthesia, the pregnant woman will be placed in the back and horizontal position, and she is in this situation for 5 minutes. Pain. Timepoint: During the intervention. Method of measurement: VAS. Age. Timepoint: During Of Intervention. Method of measurement: Year. Weight. Timepoint: During Of Intervention. Method of measurement: kilogram. First stage of Labour. Timepoint: During Of Intervention. Method of measurement: Minute. Neonate APGAR. Timepoint: During Of Intervention. Method of measurement: 1to10. Blood Pressure. Timepoint: During Of Intervention. Method of measurement: Mm Hg. Ephedrine Amount. Timepoint: During Of Intervention. Method of measurement: mg. Heart Beat. Timepoint: During Of Intervention. Method of measurement: Beat per minute. Nausea and Vomiting. Timepoint: During Of Intervention. Method of measurement: Yes/NO. Amount of Natural delivery. Timepoint: During Of Intervention. Method of measurement: Number. Petedin Amount. Timepoint: During Of Intervention. Method of measurement: mg. Second Stage Of Labour. Timepoint: During Of Intervention. Method of measurement: Minute. Vice chancellor for research in Qazvin university of medical sciences Approved 2017-04-08 Ethics Committee, Qazvin University Of Medical Sciences Bahonar Bulvar,Qazvin Qazvin Iran (Islamic Republic of)