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Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

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ClinicalTrials.gov Identifier: NCT04653506
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center

Brief Summary:
The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period

Condition or disease Intervention/treatment Phase
Pain Drug: Paracetamol 1000 mg Drug: Ibuprofen 400 mg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Masking Description: The primary investigator will be the only one to have the information about envelopes contain
Primary Purpose: Treatment
Official Title: Non - Opioid Treatments (Single Administration) for Pain During the Early Postpartum Period After Vaginal Delivery
Actual Study Start Date : November 28, 2020
Estimated Primary Completion Date : November 28, 2022
Estimated Study Completion Date : November 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: Paracetamol group
Women who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg)
Drug: Paracetamol 1000 mg
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

Experimental: Ibuprofen group
Women who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg)
Drug: Ibuprofen 400 mg
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Maximum pain location [ 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 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)


Other Outcome Measures:
  1. Effect on breastfeeding [ Time Frame: 6 hours after intervention ]
    The participants will answer a questionnaire that will describe the effect of' pain relief on a woman's ability to breastfeed. The questionnaire will ask their desire to breastfeed before giving birth, did they really manage to breastfeed, and when they started breastfeeding. The investigator will describe if there is a correlation between pain relief and the ability to breastfeed.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postpartum women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women between the ages of 18-50, who gave birth in a vaginal birth

Exclusion Criteria:

  • 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

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): NCT04653506


Contacts
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Contact: Shai Ram, MD 972 0506337159 shairam85@gmail.com
Contact: Sharon Maslovitz, MD 972527360048 MASLOVITZ@gmail.com

Locations
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Israel
Tel Aviv Medical Center Recruiting
Tel Aviv, Israel, 6423906
Contact: shai ram, MD    +972506337159    shairam85@gmail.com   
Contact: MD         
Principal Investigator: Sharon Maslovitz, MD         
Principal Investigator: Shai Ram, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: shai ram, MD Tel Aviv Medical Center
Publications:

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Responsible Party: Eli Sprecher, MD, director head of clinical trails department, principal investigator, clinical professor, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04653506    
Other Study ID Numbers: 0368-20-TLV
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center:
Post Partum Pain, Pain Relief, Non-Opioids Analgesia
Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics