Pain Management at Latent Period of Labour

Pain Management Efficiency at Latent Period of Labour

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

Study Overview

• Status: Unknown
• Conditions: Labour
• Intervention / Treatment: Drug: iv paracetamol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• latent phase of labour
• low risk

Exclusion Criteria:

• high risk
• allergy to paracetamol
• liver insufficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention and data collection; pain management by iv paracetamol	Drug: iv paracetamol; iv paracetamol; Other Names: perfalgan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score	vas	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of paracetamol	samples of blood	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	pain scores by vas scale 0-10 scale. 0 no pain- 10 sever pain	72 hours after labor , the data will be presented through study completion, an average of 1 year
pain influences	influences of pain on daily activities, BPI scale behavioral pain scale , the inflouences of pain on movement, breast feeding, taking a bath, talking with visitors, 0- no influencs, 10 very much	72 hours after labor, the data will be presented through study completion, an average of 1 year
pain experience and analgesia	analgesia, which kind of analgesia medicines had used	72 hours after labor, the data will be presented through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): April 20, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 0037-16-NHR-shnaider

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No