Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Iranian Registry of Clinical Trials
Year
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2011
INTERVENTION: 0.2 mg/kg intra venous ketamin+ 2 ?cc normal saline in intervention group 2cc Normal saline in control group as placebo 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. Placebo Treatment ‐ Drugs CONDITION: Other complications of anaesthesia during labour and delivery Pregnancy, childbirth and the puerperium. ; Other complications of anaesthesia during labour and delivery PRIMARY OUTCOME: 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. SECONDARY OUTCOME: 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). 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. 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. 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. 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. 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 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 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 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. 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. 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). 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 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. 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. 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 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). 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). INCLUSION CRITERIA: 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
Epistemonikos ID: 6788415b64bd753fdae71988e1f0e60b4800c926
First added on: Aug 22, 2024