Pethidine Analgesia on Labor Duration

NCT03882814 | Completed

• 1 other identifier: 2018.37
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Keywords

Analgesia; labor; pethidine; Active Phase

Outcome Measures

Primary Outcomes (2)

• Active phase of labor with pethidine

  The study group that accepted pethidine injection comprised of 132 patients; The active phase duration was evaluated in minutes.

  during labor

• Labor pain with pethidine

  Labor pain VAS scores were determined in both groups just prior to pethidine injection (0.hour), and 1st and 2nd hours after injection. The VAS scale represents pain with a score of 1 to 10. patients scored points on this scale and these scores were recorded. 1 point shows the least pain, 10 points the most-irresistible pain.

  during labor

Study Arms (2)

Pethidine group / study group

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.

Drug: pethidine

control group

The patients who received placebo injection were included in the control group. Saline was given in placebo.

Drug: Placebo - Concentrate

Interventions

pethidine DRUG

Pethidine 50 mg intramuscular (IM) injection was performed when cervical dilatation was at or greater than 4 cm and the cardiotocogram uterine contraction recordings of 200 Montevideo units was reached. Opioid analgesia (pethidine HCl - 50 mg I.M.) was given following amniotomy.

Pethidine group / study group

Placebo - Concentrate DRUG

Intramuscular saline was administered to the control group as placebo. Salin intramuscular (IM) injection was performed when cervical dilatation was at or greater than 4 cm and the cardiotocogram uterine contraction recordings of 200 Montevideo units was reached. salon was given following amniotomy.

control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria were nulliparous and multiparous patients with singleton pregnancies between 37 and 41 completed weeks (according to last menstrual period).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead
• Gaziosmanpasa Research and Education Hospital: collaborator

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

Related Publications (1)

• Kadirogullari P, Yalcin Bahat P, Sahin B, Gonen I, Seckin KD. The Effect of Pethidine Analgesia on Labor Duration and Maternal-Fetal Outcomes. Acta Biomed. 2021 May 12;92(2):e2021065. doi: 10.23750/abm.v92i2.10905.

  PMID: 33988155 DERIVED

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Meperidine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, M.D, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 20, 2019
• Study Start: July 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

TU (1)