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Completed

NCT Number: NCT02783508

Pethidine Versus Nitrous Oxide for Pain Relief During Labor

Systematic opioids and inhaled nitrous oxide (N2O ) are common methods for pain relief during labor. The aim of the current study is to evaluate the efficacy of systemic pethidine compared to N2O given for pain relieve in term, multiparous women in labor.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HaEmek Medical Center

Afula, 18101, Israel

About this study

Pain relief during labor and delivery is an essential part of good obstetrical care. Labor pain and its relief have implications on the course of labor, maternal and fetal outcomes and the satisfaction with childbirth overall. Many women would like to have a choice in pain relief during labor but also would like to avoid invasive methods of pain management in labor (as epidural). Both, inhaled analgesia and parenteral opioids are common pharmacological interventions aim to relieve the pain of labor.Nitrous oxide in a 50/50 mix with oxygen is the most common concentration used for labor pain management. It is self-administered via facemask, intermittently, and has rapid onset and offset effect. Main side effects, including nausea, vomiting, dizziness and drowsiness. Pethidine is one of the most frequently used opiate agonists. It can be given intravenous or intramuscularly. Its analgesic effect starts within 10-20 minutes and lasts 2-4 hours. Reported maternal side effects include nausea, vomiting and dysphoria. Pethidine may lead to changes in fetal heart rate tracing during labor, respiratory depression, impaired sucking reflex and restlessness.

Given the fact that these two routine interventions are given in different ways and have different side effects profile, the investigators aim in this randomized controlled trial to compare the analgesic effect of these two methods and their maternal and perinatal secondary effects in multiparous laboring women.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiparity (para 2 or more).
  • Term pregnancy: 37-42 weeks of gestation.
  • Singleton pregnancy.
  • Vertex presentation.
  • In labor: at least 2 contraction in ten minutes and cervical dilatation of 2 centimeters or more.

Exclusion criteria

  • Women who desire epidural as a first line analgesia during labor.
  • Women receiving pethidine during the last 24 hours (prior to entering labor room).
  • Contra-indication for vaginal delivery.
  • Contra-indication or allergic reaction to either pethidine or nitrous oxide.
  • History of drug abuse.
  • Previous cesarean delivery.

Treatment and study plan

IV Meperidine

Drug

Intravenous meperidine 50mg in 100cc NaCl 0.9% . Repeated doses (if needed): intervals of 2 hours minimum until a maximum of 4 doses.

In cases of nausea or vomiting intravenous metoclopramide 10mg will be offered to the parturient.

If pain intensity (according to visual analogue scale), 20 to 30 minutes from administration, will not decline or the parturient will ask for a different type of analgesia, inhaled nitrous oxide or epidural analgesia will be offered.

Other names: Pethidine

Nitrous Oxide

Drug

Nitrous oxide in a 50/50 mix with oxygen given via self-administered face mask. The parturient will be advised to place the mask tightly on her face and to breathe through it at the first sign of forthcoming uterine contraction. Between contractions, she will be advised not to breathe through the mask.

In cases of nausea or vomiting intravenous metoclopramide 10mg will be offered to the parturient.

If pain intensity (according to visual analogue scale), 20 to 30 minutes from administration, will not decline or the parturient will ask for a different type of analgesia, intravenous meperidine or epidural analgesia will be offered.

Other names: N2O

Primary outcomes

  1. Pain intensity

    Time frame: 20-30 minutes after drug administration.

    Visual analogue scale

Secondary outcomes

  1. Pain intensity

    Time frame: 60, 120 and 180 minutes from drug administration.

    Visual analogue scale

  2. Time from drug administration to labor.

    Time frame: 24 hours

  3. Need for additional analgesia

    Time frame: 24 hours

    Number of women that needed additional analgesia.

  4. Side effects.

    Time frame: During 60 minutes from drug administration.

    nausea, vomiting, itching, headache, mouth dryness, drowsiness

  5. Breast feeding

    Time frame: Up to 48 hours after birth

  6. Participants satisfaction and the usefulness of pain relief

    Time frame: Within 48 hours after birth

    Scale of excellent, very good, good, fair or poor.

  7. Changes in electronic fetal heart rate monitoring

    Time frame: 24 hours

  8. Occurence of meconium stained amniotic fluid

    Time frame: 24 hours

    Number of women with meconium stained amniotic fluid.

  9. Umbilical artery PH

    Time frame: Up to 5 min from birth, after performing cord clamping.

    Number of women with Umbilical artery PH less than 7.1.

  10. Apgar score

    Time frame: At 1 and 5 minutes after birth

  11. Need for respiration

    Time frame: Within 48 hours after birth

  12. Neonatal Intensive Care Unit (NICU) administration

    Time frame: Within 48 hours after birth

    Number of neonates that admitted to neonatal intensive care unit within 48 hours after birth.

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

Pethidine Versus Nitrous Oxide for Pain Relief During Labor Among Multiparous. A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 26, 2016
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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