Pain ManagementNCT07264309
Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor. Compare the Efficacy and Adverse Effects
A study testing pethidine, Tramadol and Paracetamol 1 g in people with Pain Management and Birth, run by Zohar Nachum at 1 site in Israel.
Trial summary
The goal of this intervention study is to compare the efficacy and adverse effects of pain relief during the first stage of labor using 75 mg IM pethidine versus the combination of IV 100 mg tramadol and 1000 mg paracetamol. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pain Management, Birth
- What is being tested?
- pethidine, Tramadol and Paracetamol 1 g
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Singleton Term pregnancy First stage of labor including at least 4 painful contractions in 30 min with cervical dilatation less or equal to 1 cm or 50% effacement Spontaneous or induced labor -
Who cannot join
- Previous cesarean delivery
- Malpresentation
- Multiple pregnancies
- Suspected intrauterine growth restriction < 3 percentile
- Suspected placental abruption
- History of allergy to paracetamol, tramadol or pethidine
Show all 13Show fewer
- Women with sleep apnea disorder
- Morbid obesity BMI≥40
- History of significant cardiac, liver and renal diseases
- Anti-convulsive medication consumption
- MAO inhibitors medication consumption within the last 14 days
- Non reassuring fetal heart rate monitoring (type II or III)
- Tense use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor
The goal of this intervention study is to compare the efficacy and adverse effects of pain relief during the first stage of labor using 75 mg IM pethidine versus the combination of IV 100 mg tramadol and 1000 mg paracetamol.
The investigator assume that the combination of IV tramadol and paracetamol will be more effective with less adverse effects than IM pethidine in pain relief at the first stage of labor.
Read more
The investigator primary outcome is The effect on pain relief according to numeric rating scale (NTS) in the study groups Before the administration of the drugs, fetal heart rate patterns and contractions will be recorded with cardiotocography monitor for at least 20 min. The investigator will evaluate vigilance at 30 minutes following drug administration.
NRS pain score (0-10) will be collected before administration and one hour after drug administration
- Conditions
- Pain Management, Birth
- Being tested
- pethidine, Tramadol, Paracetamol 1 g
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pethidineDrug
75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the
TramadolDrug
Women will receive intravenous infusion of 100 ml containing 100 mg of tramadol over 15 min
Paracetamol 1 gDrug
women will receive 50 ml containing 1000 mg of paracetamol IV over 15 min
| Study group | Role | What they receive |
|---|---|---|
| Combination of paracetamol and tramadol | Experimental | Women will receive intravenous infusion of 50 ml contain 1000mg paracetamol and 100ml contain 100mg tramadol over 15 min Receives: Drug: Tramadol; Drug: Paracetamol 1 g |
| Pethidine | Active comparator | 75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the Receives: Drug: pethidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect on pain relief
according to numeric rating scale (NRS), which runs from 0-10, where 0 is "no pain" and 10 is the "worst pain.
Measured: one hour after drug administration.
Secondary outcomes (6)
Women satisfactory rate by NRS- a scale between 1-5, where 1 is no satisfactory and 5- is excellent satisfactory
Measured: from enrollment up to 72 hours after the birth
Maternal adverse effects of the medications
Measured: from enrollment to 72 hours after birth
First stage of labor duration (hours)
Measured: from enrollment to 72 hours after birth
The need for additional analgesia (Epidural, pethidine IV, nitrous)
Measured: from enrollment to 72 hours after birth
Fetal and neonatal outcomes
Measured: from enrollment to 72 hours after birth
Pregnancy outcomes
Measured: from birth up to 72 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 posted4 Dec 2025
- Study start1 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zohar Nachum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zohar Nachum, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264309
- Sponsor's protocol ID
- 37-24
- Status last verified
- Dec 2024
- First submitted
- 24 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor
- ClinicalTrials.gov ID
- NCT07264309
- Acronym / sponsor ID
- 37-24
- Conditions
- Pain Management, Birth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Zohar NachumUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- 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.
The goal of this intervention study is to compare the efficacy and adverse effects of pain relief during the first stage of labor using 75 mg IM pethidine versus the combination of IV 100 mg tramadol and 1000 mg paracetamol.
The investigator assume that the combination of IV tramadol and paracetamol will be more effective with less adverse effects than IM pethidine in pain relief at the first stage of labor.
The investigator primary outcome is The effect on pain relief according to numeric rating scale (NTS) in the study groups Before the administration of the drugs, fetal heart rate patterns and contractions will be recorded with cardiotocography monitor for at least 20 min. The investigator will evaluate vigilance at 30 minutes following drug administration.
NRS pain score (0-10) will be collected before administration and one hour after drug administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of paracetamol and tramadol | Experimental | Drug: Tramadol, Drug: Paracetamol 1 gWomen will receive intravenous infusion of 50 ml contain 1000mg paracetamol and 100ml contain 100mg tramadol over 15 min |
| Pethidine | Active comparator | Drug: pethidine75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Singleton Term pregnancy First stage of labor including at least 4 painful contractions in 30 min with cervical dilatation less or equal to 1 cm or 50% effacement Spontaneous or induced labor -
Key exclusion criteria (13 listed)
- Previous cesarean delivery
- Malpresentation
- Multiple pregnancies
- Suspected intrauterine growth restriction < 3 percentile
- Suspected placental abruption
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 |
|---|---|---|
| pethidine75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the | Drug | Pethidine |
| TramadolWomen will receive intravenous infusion of 100 ml containing 100 mg of tramadol over 15 min | Drug | Combination of paracetamol and tramadol |
| Paracetamol 1 gwomen will receive 50 ml containing 1000 mg of paracetamol IV over 15 min | Drug | Combination of paracetamol and tramadol |
Primary outcome
The effect on pain relief
Time frame: one hour after drug administration.
according to numeric rating scale (NRS), which runs from 0-10, where 0 is "no pain" and 10 is the "worst pain.
6 secondary outcomes
Women satisfactory rate by NRS- a scale between 1-5, where 1 is no satisfactory and 5- is excellent satisfactory
Time frame: from enrollment up to 72 hours after the birth
Maternal adverse effects of the medications
Time frame: from enrollment to 72 hours after birth
First stage of labor duration (hours)
Time frame: from enrollment to 72 hours after birth
The need for additional analgesia (Epidural, pethidine IV, nitrous)
Time frame: from enrollment to 72 hours after birth
Fetal and neonatal outcomes
Time frame: from enrollment to 72 hours after birth
Pregnancy outcomes
Time frame: from birth up to 72 hours after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pethidine, Tramadol and Paracetamol 1 g in people with Pain Management and Birth, run by Zohar Nachum 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 1 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zohar Nachum, Prof. (+972-547696562, nachum_zo@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect on pain relief (time frame: one hour after drug administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.