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Pethidine Versus Nitrous Oxide for Pain Relief During Labor

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
IV Meperidine
Nitrous Oxide
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Labor analgesia, Nitrous Oxide, Meperidine, Multiparous, Visual analogue scale

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • HaEmek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IV Meperidine

Inhaled Nitrous Oxide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
Visual analogue scale

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2016
Last Updated
November 21, 2022
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT02783508
Brief Title
Pethidine Versus Nitrous Oxide for Pain Relief During Labor
Official Title
Pethidine Versus Nitrous Oxide for Pain Relief During Labor Among Multiparous. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Labor analgesia, Nitrous Oxide, Meperidine, Multiparous, Visual analogue scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Meperidine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Inhaled Nitrous Oxide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Meperidine
Other Intervention Name(s)
Pethidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide
Other Intervention Name(s)
N2O
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Visual analogue scale
Time Frame
20-30 minutes after drug administration.
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Visual analogue scale
Time Frame
60, 120 and 180 minutes from drug administration.
Title
Time from drug administration to labor.
Time Frame
24 hours
Title
Need for additional analgesia
Description
Number of women that needed additional analgesia.
Time Frame
24 hours
Title
Side effects.
Description
nausea, vomiting, itching, headache, mouth dryness, drowsiness
Time Frame
During 60 minutes from drug administration.
Title
Breast feeding
Time Frame
Up to 48 hours after birth
Title
Participants satisfaction and the usefulness of pain relief
Description
Scale of excellent, very good, good, fair or poor.
Time Frame
Within 48 hours after birth
Title
Changes in electronic fetal heart rate monitoring
Time Frame
24 hours
Title
Occurence of meconium stained amniotic fluid
Description
Number of women with meconium stained amniotic fluid.
Time Frame
24 hours
Title
Umbilical artery PH
Description
Number of women with Umbilical artery PH less than 7.1.
Time Frame
Up to 5 min from birth, after performing cord clamping.
Title
Apgar score
Time Frame
At 1 and 5 minutes after birth
Title
Need for respiration
Time Frame
Within 48 hours after birth
Title
Neonatal Intensive Care Unit (NICU) administration
Description
Number of neonates that admitted to neonatal intensive care unit within 48 hours after birth.
Time Frame
Within 48 hours after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raed Salim, MD
Organizational Affiliation
haemek medical center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sivan Easton, MD
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22972140
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.
Results Reference
background
PubMed Identifier
12834936
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.
Results Reference
background
PubMed Identifier
24356165
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.
Results Reference
background
PubMed Identifier
22419342
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.
Results Reference
background
PubMed Identifier
24289216
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.
Results Reference
background
PubMed Identifier
11213000
Citation
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.
Results Reference
background
PubMed Identifier
18757666
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.
Results Reference
background

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Pethidine Versus Nitrous Oxide for Pain Relief During Labor

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