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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201103133485N2
Enrollment
60
Registered
2011-06-14
Start date
2011-03-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, childbirth and the puerperium. Other complications of anaesthesia during labour and delivery

Interventions

0.2 mg/kg intra venous ketamin+ 2 ?cc normal saline in intervention group
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
2cc Normal saline in control group as placebo

Sponsors

Vice Chancellor for research, Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 measuremen

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Forozan Milani

Guilan University of Medical Sciences

forozanmilani@yahoo.com+98 13 1322 5624

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026