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Trial record 2 of 4 for:    18757666 [PUBMED-IDS]

Pethidine Versus Nitrous Oxide for Pain Relief During Labor

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ClinicalTrials.gov Identifier: NCT02783508
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Sivan Easton, 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.

Condition or disease Intervention/treatment Phase
Labor Pain Drug: IV Meperidine Drug: Nitrous Oxide Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pethidine Versus Nitrous Oxide for Pain Relief During Labor Among Multiparous. A Randomized Controlled Trial
Study Start Date : August 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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.

Other Name: Pethidine

Active Comparator: Inhaled 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.
Drug: 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.

Other Name: N2O




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 20-30 minutes after drug administration. ]
    Visual analogue scale


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783508


Contacts
Contact: Raed Salim, MD 97246494031 salim_ra@clalit.org.il

Locations
Israel
HaEmek Medical Center Recruiting
Afula, Israel, 18101
Contact: Raed Salim, MD    97246494031    salim_ra@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Study Chair: Raed Salim, MD haemek medical center
Principal Investigator: Sivan Easton, MD haemek medical center

Publications:

Responsible Party: Sivan Easton, Medical Doctor, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02783508     History of Changes
Other Study ID Numbers: 0072-016-EMC
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sivan Easton, HaEmek Medical Center, Israel:
Labor analgesia
Nitrous Oxide
Meperidine
Multiparous
Visual analogue scale

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nitrous Oxide
Meperidine
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia