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to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paracetamol group | Active Comparator | 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%]. |
|
| pethidine group | Active Comparator | 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%]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paracetamol-pethidine | Drug | 100 ml containing 1000 mg paracetamol -50 mg pethidine HCL |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of the intensity of perceived labor pain. | 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. | immediately after the intervention and up to 3 hours after the intervension |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| duration of the 2nd stage of labor | immediately from start of second stage till deliver of fetus |
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Inclusion Criteria:
Exclusion Criteria:
Clinical evidence of cephalopelvic disproportion
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Anter | Faculty of medicine-Menoufia university-shebin elkom -egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia University hospital | Shibīn al Kawm | Menoufia | 11111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33902372 | Derived | Anter ME, Abdel Attey Saleh S, Shawkey Allam S, Mohamed Nofal A. Efficacy and safety of intravenous paracetamol in management of labour pains in a low resource setting: a randomized clinical trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6320-6328. doi: 10.1080/14767058.2021.1911995. Epub 2021 Apr 26. |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
| 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 |
| 1- and 5-minutes Apgar scores. | immediately after delivery of the fetus |
| 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 |