Labor Pain
Conditions
Brief summary
to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains
Detailed description
investigators conducted a randomized clinical study included including 96 primiparous women admitted to Obstetrics and Gynecology Department, Menoufia University Hospitals, starting the study from May 2019 to March 2020 to assess the use of paracetamol intravenously versus Pethidine HCL intravenously in management of intrapartum pain. After obtaining approval from the local ethics committee, women who agreed to participate gave their signed informed consent after explanation of the trial benefits and hazards
Interventions
DRUGparacetamol-pethidine
100 ml containing 1000 mg paracetamol -50 mg pethidine HCL
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
Intervention model description
Cases were divided into 2 groups: Group I (paracetamol group): Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor \[roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%\]. Group 2 (pethidine group): Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor \[roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%\]. Randomization was done by a computer-generated randomization system. Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Primiparous * aged 18-35 years, * Term live singleton pregnancy, * Vertex presentation, * Spontaneous onset of labor at term 37-42 weeks gestation, * In active phase of of 1st stage of labour (cervix dilatation 3- 4 cm).
Exclusion criteria
Clinical evidence of cephalopelvic disproportion * Use of any kind of analgesia prior to study * Any medical disorder during pregnancy (liver or kidney impairment) * Induction of labor, Intrauterine fetal death * Evidence of fetal distress * Antenatal diagnosis of congenital malformation * Previous history of hypersensitivity to either drug * Extremes of age (i.e. below 18 or above 35) * Multiple pregnancies * Cervical dilatation more than 6 cm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of the intensity of perceived labor pain. | immediately after the intervention and up to 3 hours after the intervension | Labour pain was semi-objectively assessed using the visual analogue scale (VAS). In this technique, the patient is shown a ten cm line which represent at one end no pain and the other worst pain, and the patient is asked to point on the line where her pain lies. This scale has the added advantage that the pain can be given a numerical value. |
Secondary
| Measure | Time frame |
|---|---|
| duration of the 2nd stage of labor | immediately from start of second stage till deliver of fetus |
| need for further analgesia | immediately after the intervention till the end of first stage of labour |
| maternal dizziness, nausea and/or vomiting | immediately after the intervention till the end of first stage |
| mode of delivery (vaginal or by caesarian | immediately after the intervention |
| duration of the active phase of the 1st stage of labor | immediately from start of active phase of the 1st stage of labor till the end of first stage |
| need for neonatal resuscitation | immediately after delivery of the fetus |
| need for NICU admission | immediately after delivery of the fetus |
| Neonatal respiratory distress . | immediately after delivery of the fetus |
| 1- and 5-minutes Apgar scores. | immediately after delivery of the fetus |
Countries
Egypt
Outcome results
None listed