Pain Management at Latent Period of Labour

NCT ID: NCT03105830

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2018-06-30

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.

Conditions

Labour

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention and data collection

pain management by iv paracetamol

Group Type: EXPERIMENTAL

iv paracetamol

Intervention Type: DRUG

iv paracetamol

Interventions

iv paracetamol

iv paracetamol

Intervention Type: DRUG

Other Intervention Names

perfalgan

Eligibility Criteria

Inclusion Criteria

• latent phase of labour
• low risk

Exclusion Criteria

• high risk
• allergy to paracetamol
• liver insufficiency

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Oleg Shnaider

head of delivery room

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0037-16-NHR-shnaider

Identifier Type: -

Identifier Source: org_study_id