Pethidine Versus Nitrous Oxide for Pain Relief During Labor

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783508
• Other study ID #: 0072-016-EMC
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: May 2019

Study information

• Verified date: November 2022
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• IV Meperidine
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.
• 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, 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.

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (7)

Howell CJ, Kidd C, Roberts W, Upton P, Lucking L, Jones PW, Johanson RB. A randomised controlled trial of epidural compared with non-epidural analgesia in labour. BJOG. 2001 Jan;108(1):27-33. doi: 10.1111/j.1471-0528.2001.00012.x. — View Citation

Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2. — View Citation

Keskin HL, Keskin EA, Avsar AF, Tabuk M, Caglar GS. Pethidine versus tramadol for pain relief during labor. Int J Gynaecol Obstet. 2003 Jul;82(1):11-6. doi: 10.1016/s0020-7292(03)00047-x. — View Citation

Klomp T, van Poppel M, Jones L, Lazet J, Di Nisio M, Lagro-Janssen AL. Inhaled analgesia for pain management in labour. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD009351. doi: 10.1002/14651858.CD009351.pub2. — View Citation

Likis FE, Andrews JC, Collins MR, Lewis RM, Seroogy JJ, Starr SA, Walden RR, McPheeters ML. Nitrous oxide for the management of labor pain: a systematic review. Anesth Analg. 2014 Jan;118(1):153-67. doi: 10.1213/ANE.0b013e3182a7f73c. Erratum In: Anesth Analg. 2014 Apr;118(4):885. — View Citation

Macones GA, Hankins GD, Spong CY, Hauth J, Moore T. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. Obstet Gynecol. 2008 Sep;112(3):661-6. doi: 10.1097/AOG.0b013e3181841395. — View Citation

Wee MY, Tuckey JP, Thomas PW, Burnard S. A comparison of intramuscular diamorphine and intramuscular pethidine for labour analgesia: a two-centre randomised blinded controlled trial. BJOG. 2014 Mar;121(4):447-56. doi: 10.1111/1471-0528.12532. Epub 2013 Dec 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Visual analogue scale	20-30 minutes after drug administration.
Secondary	Pain intensity	Visual analogue scale	60, 120 and 180 minutes from drug administration.
Secondary	Time from drug administration to labor.		24 hours
Secondary	Need for additional analgesia	Number of women that needed additional analgesia.	24 hours
Secondary	Side effects.	nausea, vomiting, itching, headache, mouth dryness, drowsiness	During 60 minutes from drug administration.
Secondary	Breast feeding		Up to 48 hours after birth
Secondary	Participants satisfaction and the usefulness of pain relief	Scale of excellent, very good, good, fair or poor.	Within 48 hours after birth
Secondary	Changes in electronic fetal heart rate monitoring		24 hours
Secondary	Occurence of meconium stained amniotic fluid	Number of women with meconium stained amniotic fluid.	24 hours
Secondary	Umbilical artery PH	Number of women with Umbilical artery PH less than 7.1.	Up to 5 min from birth, after performing cord clamping.
Secondary	Apgar score		At 1 and 5 minutes after birth
Secondary	Need for respiration		Within 48 hours after birth
Secondary	Neonatal Intensive Care Unit (NICU) administration	Number of neonates that admitted to neonatal intensive care unit within 48 hours after birth.	Within 48 hours after birth