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Comparing the analgesic effect of intrathecal Sufentanil with intravenous Acetaminophen in combination with low-dose Ketamine on labor pain

Comparing the analgesic effect of intrathecal Sufentanil with intravenous Acetaminophen in combination with low-dose ketamine onl abor pain

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017082935979N1
Enrollment
120
Registered
2017-11-14
Start date
2017-04-21
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

Analgesia in Labour. Maternal complications arising from the administration of a general or local anaesthetic, analgesic or other sedation during labour and delivery

Interventions

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
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
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 anest

Sponsors

Vice chancellor for research in Qazvin university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 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 ….).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: During the intervention. Method of measurement: VAS.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMona Koochak Pour

Qazvin University Of Medical Sciense

Mon_470@yahoo.com+98 28 3323 6375

Outcome results

None listed

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