PainNCT04653506
Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period
A study testing Paracetamol 1000 mg and Ibuprofen 400 mg in people with Pain, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Paracetamol 1000 mg and Ibuprofen 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Nov 2020to 6 Jul 2023
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 18-50, who gave birth in a vaginal birth
Who cannot join
- Sensitivity to Paracetamol or Ibuprofen
- After cesarean section
- Received analgesia prior to study recruitment
- Perineal tears grade 3 \ 4
- Women with chronic pain, rheumatic disease, fibromyalgia, or trauma
- Women with a diagnosis or medication for anxiety or depression
- Dropout for women whose newborns needed respiratory support with intubation, cooling, prolonged hospitalization in NICU exceeding one week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non - Opioid Treatments (Single Administration) for Pain During the Early Postpartum Period After Vaginal Delivery
The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period
Read the detailed description
Postpartum pain is a common problem that leads to difficulties in basic daily activities, overuse of opioid medications, and even impaired breastfeeding ability. Non-opioid analgesia may play an essential role in reducing pain and improving the postpartum period including the ability to breastfeed and caring for the newborn.
This study will compare non-opioid treatment - 1000 mg Paracetamol versus 400 mg Ibuprofen in order to determine the optimal pain relief treatment in the early postpartum period that may decrease the use of opioid analgesia.
The investigators will evaluate the pain by the Numerical Rating Scale (NRS) index in the early postpartum period. The evaluation will conduct at 4-time points - while the women taking the pain relief (time 0), an hour later (time 1), 4, and 6 hours later (time 4 and time 6).
The investigators will compare the analgetic effect of each drug and evaluate the need for additional analgesia whether opioid or not.
Furthermore, the investigators will examine when women sought pain relief and whether pain relief contributes to the ability of Breastfeeding.
- Conditions
- Pain
- Being tested
- Paracetamol 1000 mg, Ibuprofen 400 mg
- Keywords
- Post Partum Pain, Pain Relief, Non-Opioids Analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol 1000 mgDrug
Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg
Ibuprofen 400 mgDrug
Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol group | Experimental | Women who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg) Receives: Drug: Paracetamol 1000 mg |
| Ibuprofen group | Experimental | Women who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg) Receives: Drug: Ibuprofen 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief after treatment with Paracetamol or Ibuprofen
After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The pain rating will be on the Numeric Rating Scale (NRS) that labeled from zero (no pain) to ten ((worst pain).
Measured: 6 hours after intervention
Secondary outcomes (1)
Maximum pain location
After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The questionnaire will describe the maximal pain location area and the effectiveness of analgesic treatment in this area (by rating the pain on the NRS). The questionnaire will be at the time of taking the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6)
Measured: 6 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start28 Nov 2020
- Primary completion1 Jul 2022
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- * Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia (NRS \<3) * Pain Reliefs will be given in a double-blind mechanism, in closed envelopes * The envelopes will contain Paracetamol 1000 mg or Ibuprofen 400 mg * Women participating in the study will answer a questionnaire to characterize the pain while taking the pain relief (time 0), an hour later (time 1), 4 and 6 hours later (time 4 and time 6)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shmuel Kivity, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- shai ram, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653506
- Sponsor's protocol ID
- 0368-20-TLV
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
PubMed 15507941Fahey JO. Best Practices in Management of Postpartum Pain. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):126-136. doi: 10.1097/JPN.0000000000000241.
PubMed 28277399Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
PubMed 18818022Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863.
PubMed 31348508Deussen AR, Ashwood P, Martis R. Analgesia for relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2011 May 11;(5):CD004908. doi: 10.1002/14651858.CD004908.pub2.
PubMed 21563142Wuytack F, Smith V, Cleary BJ. Oral non-steroidal anti-inflammatory drugs (single dose) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2016 Jul 14;7(7):CD011352. doi: 10.1002/14651858.CD011352.pub2.
PubMed 27412362Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet. 1998 Feb;34(2):101-54. doi: 10.2165/00003088-199834020-00002.
PubMed 9515184Chou D, Abalos E, Gyte GM, Gulmezoglu AM. Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD008407. doi: 10.1002/14651858.CD008407.pub2.
PubMed 23440827Ram S, Madar D, Ram HS, Peleg G, Lior Y, Greenfeld A, Yakov G, Yogev Y, Maslovitz S. Paracetamol versus ibuprofen for early postpartum pain control: a randomized controlled trial. Arch Gynecol Obstet. 2025 Jul;312(1):51-57. doi: 10.1007/s00404-024-07797-4. Epub 2024 Nov 5.
PubMed 39499309
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non - Opioid Treatments (Single Administration) for Pain During the Early Postpartum Period After Vaginal Delivery
- ClinicalTrials.gov ID
- NCT04653506
- Acronym / sponsor ID
- 0368-20-TLV
- Conditions
- Pain
- Keywords
- Post Partum Pain, Pain Relief, Non-Opioids Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 28 Nov 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 4 Dec 2020 (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 investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period
Detailed description
Postpartum pain is a common problem that leads to difficulties in basic daily activities, overuse of opioid medications, and even impaired breastfeeding ability. Non-opioid analgesia may play an essential role in reducing pain and improving the postpartum period including the ability to breastfeed and caring for the newborn.
This study will compare non-opioid treatment - 1000 mg Paracetamol versus 400 mg Ibuprofen in order to determine the optimal pain relief treatment in the early postpartum period that may decrease the use of opioid analgesia.
The investigators will evaluate the pain by the Numerical Rating Scale (NRS) index in the early postpartum period. The evaluation will conduct at 4-time points - while the women taking the pain relief (time 0), an hour later (time 1), 4, and 6 hours later (time 4 and time 6).
The investigators will compare the analgetic effect of each drug and evaluate the need for additional analgesia whether opioid or not.
Furthermore, the investigators will examine when women sought pain relief and whether pain relief contributes to the ability of Breastfeeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- * Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia (NRS <3) * Pain Reliefs will be given in a double-blind mechanism, in closed envelopes * The envelopes will contain Paracetamol 1000 mg or Ibuprofen 400 mg * Women participating in the study will answer a questionnaire to characterize the pain while taking the pain relief (time 0), an hour later (time 1), 4 and 6 hours later (time 4 and time 6)
| Arm | Type | Receives |
|---|---|---|
| Paracetamol group | Experimental | Drug: Paracetamol 1000 mgWomen who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg) |
| Ibuprofen group | Experimental | Drug: Ibuprofen 400 mgWomen who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women between the ages of 18-50, who gave birth in a vaginal birth
Key exclusion criteria (7 listed)
- Sensitivity to Paracetamol or Ibuprofen
- After cesarean section
- Received analgesia prior to study recruitment
- Perineal tears grade 3 \ 4
- Women with chronic pain, rheumatic disease, fibromyalgia, or trauma
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 |
|---|---|---|
| Paracetamol 1000 mgWomen participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg | Drug | Paracetamol group |
| Ibuprofen 400 mgWomen participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg | Drug | Ibuprofen group |
Primary outcome
Pain relief after treatment with Paracetamol or Ibuprofen
Time frame: 6 hours after intervention
After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The pain rating will be on the Numeric Rating Scale (NRS) that labeled from zero (no pain) to ten ((worst pain).
1 secondary outcome
Maximum pain location
Time frame: 6 hours after intervention
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 20 Feb 2024.
- Background: PubMed 15507941Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
- Background: PubMed 28277399Fahey JO. Best Practices in Management of Postpartum Pain. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):126-136. doi: 10.1097/JPN.0000000000000241.
- Background: PubMed 18818022Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
- Background: PubMed 31348508Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863.
- Background: PubMed 21563142Deussen AR, Ashwood P, Martis R. Analgesia for relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2011 May 11;(5):CD004908. doi: 10.1002/14651858.CD004908.pub2.
- Background: PubMed 27412362Wuytack F, Smith V, Cleary BJ. Oral non-steroidal anti-inflammatory drugs (single dose) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2016 Jul 14;7(7):CD011352. doi: 10.1002/14651858.CD011352.pub2.
- Background: PubMed 9515184Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet. 1998 Feb;34(2):101-54. doi: 10.2165/00003088-199834020-00002.
- Background: PubMed 23440827Chou D, Abalos E, Gyte GM, Gulmezoglu AM. Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD008407. doi: 10.1002/14651858.CD008407.pub2.
- Derived from this study: PubMed 39499309Ram S, Madar D, Ram HS, Peleg G, Lior Y, Greenfeld A, Yakov G, Yogev Y, Maslovitz S. Paracetamol versus ibuprofen for early postpartum pain control: a randomized controlled trial. Arch Gynecol Obstet. 2025 Jul;312(1):51-57. doi: 10.1007/s00404-024-07797-4. Epub 2024 Nov 5.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
shai ram, MD principal investigator
Tel Aviv 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 Paracetamol 1000 mg and Ibuprofen 400 mg in people with Pain, run by Tel-Aviv Sourasky Medical Center 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 7 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 20 Feb 2024. 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 relief after treatment with Paracetamol or Ibuprofen (time frame: 6 hours after intervention). 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 NCT04653506, which also lists 9 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 20 Feb 2024.