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Clinical Trials/NCT03105830
NCT03105830
Unknown
Not Applicable

Pain Management Efficiency at Latent Period of Labour

Western Galilee Hospital-Nahariya0 sites150 target enrollmentMay 2017
ConditionsLabour
Interventionsiv paracetamol

Overview

Phase
Not Applicable
Intervention
iv paracetamol
Conditions
Labour
Sponsor
Western Galilee Hospital-Nahariya
Enrollment
150
Primary Endpoint
pain score
Last Updated
9 years ago

Overview

Brief Summary

Examine the effectiveness of an analgesic in PERFALGAN maternity latent phase of labor.

Examine the safety in PERFALGAN in the mother and the newborn in terms of the level of drug in blood

Detailed Description

Maternity are latent or first stage of labor and complained of pain at the level of 4 or higher on a scale VAS, and are not in risk (HIGH RISK). And did not receive analgesics within 4 hours. The sample will consist of at least 100 women in labor. 1. women, will be identified in the reception room of a delivery room by midwives. 2. The research team will ask for consent after receiving an explanation and confirmation of understanding. 3. The midwife will perform and will record pain assessment by visual analog scores . 4. Maternity reported pain level 4 and above will be asked four questions out of data collection and offered them treatment I.V. PARACETAMOL 1gr as directed by the physician. 5. After giving I.V. PARACETAMOL 1g, carried out and documented estimate of the pain returns (by visual analog scores) after an hour wait at any time to wait four hours and two hours after birth. In cases of an outbreak of pain can give one of the following: Option A: Another portion of the I.V. PARACETAMOL 1gr within 4-6 hours the previous dose. The maximum daily dose of 4 grams. Option B: N2O by procedure A third possibility: Epidural physician approval 6. At the end of the birth fetal blood sample taken from the placenta for testing the level of paracetamol. 7. At the end of a blood sample taken birth for the client in liver function tests. 8. Interview woman with postpartum questionnaire will be made during her stay in the maternity ward. Filling out a questionnaire that includes demographic data and about the process of birth, medical records.

Registry
clinicaltrials.gov
Start Date
May 2017
End Date
June 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Oleg Shnaider

head of delivery room

Western Galilee Hospital-Nahariya

Eligibility Criteria

Inclusion Criteria

  • latent phase of labour

Exclusion Criteria

  • high risk
  • allergy to paracetamol
  • liver insufficiency

Arms & Interventions

intervention and data collection

pain management by iv paracetamol

Intervention: iv paracetamol

Outcomes

Primary Outcomes

pain score

Time Frame: pain assessmant by vas scale during the latent phase of labor at delivery room. the data will be presented through study completion, an average of 1 year

vas

Secondary Outcomes

  • level of paracetamol(at the end of labor , blood samples from the mother and from the umbelical cord. the data will be presented through study completion, an average of 1 year)
  • pain experience(72 hours after labor , the data will be presented through study completion, an average of 1 year)
  • pain influences(72 hours after labor, the data will be presented through study completion, an average of 1 year)
  • pain experience and analgesia(72 hours after labor, the data will be presented through study completion, an average of 1 year)

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