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Pain Management at Latent Period of Labour

W

Western Galilee Hospital-Nahariya

Status

Unknown

Conditions

Labour

Treatments

Drug: iv paracetamol

Study type

Interventional

Funder types

Other

Identifiers

NCT03105830
0037-16-NHR-shnaider

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • latent phase of labour
  • low risk

Exclusion criteria

  • high risk
  • allergy to paracetamol
  • liver insufficiency

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

intervention and data collection
Experimental group
Description:
pain management by iv paracetamol
Treatment:
Drug: iv paracetamol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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