Labor PainNCT02783508
Pethidine Versus Nitrous Oxide for Pain Relief During Labor
A study testing IV Meperidine and Nitrous Oxide in people with Labor Pain, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- IV Meperidine and Nitrous Oxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pethidine Versus Nitrous Oxide for Pain Relief During Labor Among Multiparous. A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Labor Pain
- Being tested
- IV Meperidine, Nitrous Oxide
- Keywords
- Labor analgesia, Nitrous Oxide, Meperidine, Multiparous, Visual analogue scale
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV MeperidineDrug
Also called Pethidine
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 OxideDrug
Also called N2O
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nitrous Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual analogue scale
Measured: 20-30 minutes after drug administration.
Secondary outcomes (12)
Pain intensity
Visual analogue scale
Measured: 60, 120 and 180 minutes from drug administration.
Time from drug administration to labor.
Measured: 24 hours
Need for additional analgesia
Number of women that needed additional analgesia.
Measured: 24 hours
Side effects.
nausea, vomiting, itching, headache, mouth dryness, drowsiness
Measured: During 60 minutes from drug administration.
Breast feeding
Measured: Up to 48 hours after birth
Participants satisfaction and the usefulness of pain relief
Scale of excellent, very good, good, fair or poor.
Measured: Within 48 hours after birth
Changes in electronic fetal heart rate monitoring
Measured: 24 hours
Occurence of meconium stained amniotic fluid
Number of women with meconium stained amniotic fluid.
Measured: 24 hours
Umbilical artery PH
Number of women with Umbilical artery PH less than 7.1.
Measured: Up to 5 min from birth, after performing cord clamping.
Apgar score
Measured: At 1 and 5 minutes after birth
Need for respiration
Measured: Within 48 hours after birth
Neonatal Intensive Care Unit (NICU) administration
Number of neonates that admitted to neonatal intensive care unit within 48 hours after birth.
Measured: Within 48 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sivan Easton, HaEmek Medical Center, Israel
- Investigators
- Raed Salim, MD, Study chair, haemek medical centerSivan Easton, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783508
- Sponsor's protocol ID
- 0072-016-EMC
- Status last verified
- Nov 2022
- First submitted
- 18 May 2016
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22972140Keskin 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.
PubMed 12834936Likis 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.
PubMed 24356165Jones 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.
PubMed 22419342Wee 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.
PubMed 24289216Howell 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.
PubMed 11213000Macones 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.
PubMed 18757666Zuarez-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.
PubMed 36701604
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pethidine Versus Nitrous Oxide for Pain Relief During Labor Among Multiparous. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02783508
- Acronym / sponsor ID
- 0072-016-EMC
- Conditions
- Labor Pain
- Keywords
- Labor analgesia, Nitrous Oxide, Meperidine, Multiparous, Visual analogue scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Meperidine | Active comparator | Drug: IV MeperidineIntravenous 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. |
| Inhaled Nitrous Oxide | Active comparator | Drug: Nitrous OxideNitrous 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV MeperidineAlso: PethidineIntravenous 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. | Drug | IV Meperidine |
| Nitrous OxideAlso: N2ONitrous 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. | Drug | Inhaled Nitrous Oxide |
Primary outcome
Pain intensity
Time frame: 20-30 minutes after drug administration.
Visual analogue scale
12 secondary outcomes
Pain intensity
Time frame: 60, 120 and 180 minutes from drug administration.
Time from drug administration to labor.
Time frame: 24 hours
Need for additional analgesia
Time frame: 24 hours
Side effects.
Time frame: During 60 minutes from drug administration.
Breast feeding
Time frame: Up to 48 hours after birth
Participants satisfaction and the usefulness of pain relief
Time frame: Within 48 hours after birth
Changes in electronic fetal heart rate monitoring
Time frame: 24 hours
Occurence of meconium stained amniotic fluid
Time frame: 24 hours
Umbilical artery PH
Time frame: Up to 5 min from birth, after performing cord clamping.
Apgar score
Time frame: At 1 and 5 minutes after birth
Need for respiration
Time frame: Within 48 hours after birth
Neonatal Intensive Care Unit (NICU) administration
Time frame: Within 48 hours after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Background: PubMed 22972140Klomp 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.
- Background: PubMed 12834936Keskin 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.
- Background: PubMed 24356165Likis 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.
- Background: PubMed 22419342Jones 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.
- Background: PubMed 24289216Wee 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.
- Background: PubMed 11213000Howell 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.
- Background: PubMed 18757666Macones 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.
- Derived from this study: PubMed 36701604Zuarez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raed Salim, MD study chair
haemek medical center
Sivan Easton, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV Meperidine and Nitrous Oxide in people with Labor Pain, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 20-30 minutes after drug administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02783508, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.