IRCT201103133485N2 IRCT 2011-06-14 Vice Chancellor for research, Guilan University of Medical Sciences To study the effect of intravenous low dose ketamin on the severity of pain and the need for analgesics in patients operated with cesarean section with spinal anesthesia Scientific title:To study the effect of intravenous low dose ketamin on the severity of pain and the need for analgesics in patients operated with cesarean section with spinal anesthesia in Al-Zahra hospital during2011 2011-03-21 anticipated 60 Complete https://irct.ir/trial/3596 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Pregnancy, childbirth and the puerperium. Intervention 1: 2cc Normal saline in control group as placebo. Intervention 2: 0.2 mg/kg intra venous ketamin+ 2 ‍cc normal saline in intervention group.

public Dr Forozan Milani

Reproduction Health Research Center, Al-Zahra hospital, Namjo street

Rasht Iran (Islamic Republic of) +98 13 1322 5624 forozanmilani@yahoo.com Guilan University of Medical Sciences scientific Dr Forozan Milani

Reproductive health Research Center, Al-Zahra Hospital, Namjoo Avenue

Rasht Iran (Islamic Republic of) +98 32 25624 forozanmilani@yahoo.com Guilan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria's: 1) Pregnant women with single pregnancy, term, candidate for elective cesarean, 2) Cesarean with pfanenstail incision, 3) No history of drug abuse, 4) Absence of chronic disease such as diabetes mellitus, hypertension, preeclampsia, infection, 5) Surgery performed with the spinal anesthesia by using epinephrined lidocaine, 6) No history of surgery, 7) Having a level of intelligence for optimum cooperation, 8)ASA1 class, 9) Patient with pain score more than 5. Exclusion criteria's: 1) Bleeding after surgery, 2) Definite sensitivity to ketamin, 3) Mental and psychological problems., 4) Contraindication for spinal anesthesia, 5) Past history of hypertension, 6) Increased intracranial pressure. 7) Past history of seizure, 8) Past history of hallucination after ketamin, 9) Class ASA > 1 15 years 45 years Female O74.8 Other complications of anaesthesia during labour and delivery Placebo Treatment - Drugs 2cc Normal saline in control group as placebo 0.2 mg/kg intra venous ketamin+ 2 ‍cc normal saline in intervention group Determining the effect of low dose intra venous ketamin compared with intra venous Normal saline on the severity of pain and the need for analgesic in cesarean patients with spinal anesthesia. Timepoint: 0,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean. Method of measurement: Pain score in visual scale in 0,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean section, the time of the first request analgesic, total received analgesics. Comparing the pain score after surgery in patients with intra venous ketamin versus intra venous Normal saline group. Timepoint: 0,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean section. Method of measurement: Pain visual scale. Determining the relative frequency of hallucination in group with intravenous ketamin. Timepoint: First 24 hours after cesarean section. Method of measurement: According to patient's answers. Determining the time point from ending cesarean section to the first dose of analgesic in patients with intra venous ketamin. Timepoint: The first 24 hours after cesarean section. Method of measurement: Time of the first request for analgesic (suppository diclofenac). Determining newborn apgar score in group using intra venous Normal saline. Timepoint: First and fifth minutes after birth. Method of measurement: Including 5 sections: heart rate, breathing, effort muscular tone, reflexes, color. Comparing the newborn mean apgar in using Normal saline versus intra venous ketamin. Timepoint: First and fifth minutes after birth. Method of measurement: Including 5 sections: heart rate, breathing, effort muscular tone, reflexes, color. Determining the relative frequency of complications (vomiting, nausea, headache) in patients using intra venous ketamin. Timepoint: First 24 hours after cesarean section. Method of measurement: Nausea and headache: according to patient’s words. Vomiting : observation expulsion of content with pressure upper gastro intestinal. Determining the relative frequency of complications (vomiting. nausea, headache) in patient by using Normal saline. Timepoint: First 24 hours after cesarean section. Method of measurement: Nausea and headache: according to patient’s words. Vomiting: Observation expulsion of content with pressure upper gastro intestinal. Comparing the relative frequency in group with intra venous ketmin versus intravenous Normal saline. Timepoint: First 24 hours after cesarean section. Method of measurement: Nausea and headache: according to patient’s words. Vomiting: observation expulsion of content with pressure upper gastro intestinal. Determining newborn apgar score in group using intra venous ketamin. Timepoint: First and fifth minutes after birth. Method of measurement: Including 5 sections: heart rate, breathing, effort muscular tone, reflexes, color. Determining the time point from ending cesarean section the first dose of analgesic in patients in Normal saline group. Timepoint: The first 24 hours after cesarean section. Method of measurement: Time of the first request for analgesic (diclofenac suppository). Comparing the time point from ending cesarean section to the first analgesic in group with intra venous ketamin versus intra venous Normal Saline group. Timepoint: The first 24 hours after cesarean section. Method of measurement: Time of the first request for analgesic (Diclofenac suppository). Determining the pain score after surgery in patients with cesarean with spinal anesthesia using intra venous normal saline. Timepoint: ,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean section. Method of measurement: Pain visual scale. Comparing the mean dose of pethidine in group with intra venous ketamin versus intra venous Normal saline group. Timepoint: First 24 hours after cesarean section. Method of measurement: Dose of used pethidine. (mg/kg). Determining the pain score after surgery in patients with cesarean with spinal anesthesia using intra venous ketamin. Timepoint: 0,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean section. Method of measurement: Pain visual scale. Determining the mean dose of used pethidin in group of intra venous ketamin. Timepoint: First 24 hours after cesarean. Method of measurement: Dose of used pethidin. (mg/kg). Determining the mean dose of used pethidin in group of using Normal saline. Timepoint: First 24 hours after cesarean section. Method of measurement: Dose of used pethidin. (mg/kg). Comparing the mean dose of sodium diclofenac suppository in patient using intra venous ketamin versus Normal saline. Timepoint: First 24 hours after cesarean section. Method of measurement: Score more than 5 in pain visual scale. Determining mean dose used sodium diclofenac suppository in the group by using Normal saline. Timepoint: First 24 hours after cesarean. Method of measurement: Number of used suppositories. Determining of the mean dose of sodium diclofenac suppository in group using intra venous ketamin. Timepoint: The first 24 hours after cesarean. Method of measurement: Number of used suppository. Vice Chancellor for research, Guilan University of Medical Sciences Approved 2011-03-14 Ethic committee Guilan University of Medical Sciences Melat st, Namjoo Ave Rasht Iran (Islamic Republic of)