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Pethidine Analgesia on Labor Duration

K

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Conditions

Labor Pain

Treatments

Drug: pethidine
Drug: Placebo - Concentrate

Study type

Observational

Funder types

Other

Identifiers

NCT03882814
2018.37

Details and patient eligibility

About

Although opioid analgesics are used to treat labor pain, there are still concerns about their side effects.

The researchers in this study; aimed to evaluate the effect of pethidine on active phase duration of labor, labor pain and maternal-neonatal.

50 mg pethidine will be administered intramuscularly to the cases to be included in the study group. The patients in the control group will be given placebo injections.

Vital signs of all cases included in the study will be checked at 0, 5, 15, 30, 45 and 60 minutes. Pain will also be assessed by Visual Analogue Scale (VAS) before injection and at the 1st and 2nd hour after injection. Delivery times, maternal side effects, neonatal apgar scores and fetal findings will be recorded.

Enrollment

240 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • nullipar-multiparous patients;
  • singleton pregnancies 37- 41 weeks (by the last menstrual period).

Exclusion criteria

  • maternal respiratory rate < 8 /min,
  • maternal bradycardia (<60 bpm),
  • major fetal congenital anomalies,
  • uterine scar presence from previous pregnancies,
  • malpresentation,
  • antepartum hemorrhage,
  • multiple pregnancy,
  • labor induction,
  • chronic systemic disease,
  • rupture fetal membranes,
  • epidural analgesia.

Trial design

240 participants in 2 patient groups

Pethidine group / study group
Description:
Study group; patients given pethidine; The partogram was recorded during delivery. Cervical examination was performed at 2 hour intervals. Recorded in the file. 4 cm and greater cervical dilatation; 50 mg intramuscular (IM) injection was given to pethidine. 200 Montevideo units uterine contractions were reached. Maternal vital signs, maternal complications and neonatal APGAR scores were recorded by the clinician 0-5-15-30-45-60 minutes after pethidine injection.
Treatment:
Drug: pethidine
control group
Description:
The patients who received placebo injection were included in the control group. Saline was given in placebo.
Treatment:
Drug: Placebo - Concentrate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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