NCT02783508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

2.7 years

First QC Date

May 18, 2016

Last Update Submit

November 21, 2022

Conditions

Labor Pain

Keywords

Labor analgesiaNitrous OxideMeperidineMultiparousVisual analogue scale

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Visual analogue scale

    20-30 minutes after drug administration.

Secondary Outcomes (12)

  • Pain intensity

    60, 120 and 180 minutes from drug administration.

  • Time from drug administration to labor.

    24 hours

  • Need for additional analgesia

    24 hours

  • Side effects.

    During 60 minutes from drug administration.

  • Breast feeding

    Up to 48 hours after birth

  • +7 more secondary outcomes

Study Arms (2)

IV Meperidine

ACTIVE COMPARATOR

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.

Drug: IV Meperidine

Inhaled Nitrous Oxide

ACTIVE COMPARATOR

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.

Drug: Nitrous Oxide

Interventions

IV MeperidineDRUG

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.

Also known as: Pethidine
IV Meperidine
Nitrous OxideDRUG

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.

Also known as: N2O
Inhaled Nitrous Oxide

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek Medical Center

Afula, 18101, Israel

Location

Related Publications (8)

  • 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;2012(9):CD009351. doi: 10.1002/14651858.CD009351.pub2.

    PMID: 22972140BACKGROUND

  • 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.

    PMID: 12834936BACKGROUND

  • 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.

    PMID: 24356165BACKGROUND

  • 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.

    PMID: 22419342BACKGROUND

  • 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.

    PMID: 24289216BACKGROUND

  • 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.

    PMID: 11213000BACKGROUND

  • 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.

    PMID: 18757666BACKGROUND

  • Zuarez-Easton S, Zafran N, Garmi G, Dagilayske D, Inbar S, Salim R. Meperidine Compared With Nitrous Oxide for Intrapartum Pain Relief in Multiparous Patients: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jan 1;141(1):4-10. doi: 10.1097/AOG.0000000000005011. Epub 2022 Dec 2.

    PMID: 36701604DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

MeperidineNitrous Oxide

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingNitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Raed Salim, MD

    haemek medical center

    STUDY CHAIR

  • Sivan Easton, MD

    haemek medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 26, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

November 25, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)