Pain Management at Latent Period of Labour
- Registration Number
- NCT03105830
- Lead Sponsor
- Western Galilee Hospital-Nahariya
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 150
- latent phase of labour
- low risk
- high risk
- allergy to paracetamol
- liver insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description intervention and data collection iv paracetamol pain management by iv paracetamol
- Primary Outcome Measures
Name Time Method pain score 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 Outcome Measures
Name Time Method 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 samples of blood
pain experience 72 hours after labor , the data will be presented through study completion, an average of 1 year pain scores by vas scale 0-10 scale. 0 no pain- 10 sever pain
pain influences 72 hours after labor, the data will be presented through study completion, an average of 1 year 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
pain experience and analgesia 72 hours after labor, the data will be presented through study completion, an average of 1 year analgesia, which kind of analgesia medicines had used