Clinical trial NCT02783508: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Labor analgesia
Nitrous Oxide
Meperidine
Multiparous
Visual analogue scale
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pain intensity
timeFrame: 20-30 minutes after drug administration.
Secondary outcomes:
measure: Pain intensity
timeFrame: 60, 120 and 180 minutes from drug administration.
measure: Time from drug administration to labor.
timeFrame: 24 hours
measure: Need for additional analgesia
timeFrame: 24 hours
measure: Side effects.
timeFrame: During 60 minutes from drug administration.
measure: Breast feeding
timeFrame: Up to 48 hours after birth
measure: Participants satisfaction and the usefulness of pain relief
timeFrame: Within 48 hours after birth
measure: Changes in electronic fetal heart rate monitoring
timeFrame: 24 hours
measure: Occurence of meconium stained amniotic fluid
timeFrame: 24 hours
measure: Umbilical artery PH
timeFrame: Up to 5 min from birth, after performing cord clamping.
measure: Apgar score
timeFrame: At 1 and 5 minutes after birth
measure: Need for respiration
timeFrame: Within 48 hours after birth
measure: Neonatal Intensive Care Unit (NICU) administration
timeFrame: Within 48 hours after birth
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: haemek medical center
name: Raed Salim, MD
role: STUDY_CHAIR
affiliation: haemek medical center
name: Sivan Easton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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;2012(9):CD009351. doi: 10.1002/14651858.CD009351.pub2.
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.
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.
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.
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.
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.
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.