Pethidine Versus Nitrous Oxide for Pain Relief During Labor

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Drug: IV Meperidine; Drug: Nitrous Oxide

• Registration Number: NCT02783508
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-26
• Study Start: 2016-08
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 214

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IV Meperidine	IV Meperidine	Intravenous injection of meperidine 50mg given in 100cc NaCl 0.9% over 10 minutes. Repeated doses (if needed) will be given in intervals of 2 hours minimum until a maximum of 4 doses.
Inhaled Nitrous Oxide	Nitrous Oxide	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, the parturient will be advised not to breath through the mask.

Primary Outcome Measures

Name	Time	Method
Pain intensity	20-30 minutes after drug administration.	Visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Breast feeding	Up to 48 hours after birth
Participants satisfaction and the usefulness of pain relief	Within 48 hours after birth	Scale of excellent, very good, good, fair or poor.
Pain intensity	60, 120 and 180 minutes from drug administration.	Visual analogue scale
Time from drug administration to labor.	24 hours
Need for additional analgesia	24 hours	Number of women that needed additional analgesia.
Side effects.	During 60 minutes from drug administration.	nausea, vomiting, itching, headache, mouth dryness, drowsiness
Changes in electronic fetal heart rate monitoring	24 hours
Occurence of meconium stained amniotic fluid	24 hours	Number of women with meconium stained amniotic fluid.
Umbilical artery PH	Up to 5 min from birth, after performing cord clamping.	Number of women with Umbilical artery PH less than 7.1.
Apgar score	At 1 and 5 minutes after birth
Need for respiration	Within 48 hours after birth
Neonatal Intensive Care Unit (NICU) administration	Within 48 hours after birth	Number of neonates that admitted to neonatal intensive care unit within 48 hours after birth.

Trial Locations

Locations (1)

HaEmek Medical Center; 🇮🇱 Afula, Israel