Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

Study Overview
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Brief Summary
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to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains

Detailed Description
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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

Official Title
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Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain in a Low Resource Setting

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: paracetamol-pethidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracetamol group<br>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%]. | Drug: paracetamol-pethidine<br>* 100 ml containing 1000 mg paracetamol -50 mg pethidine HCL<br>|
| Active Comparator: pethidine group<br>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%]. | Drug: paracetamol-pethidine<br>* 100 ml containing 1000 mg paracetamol -50 mg pethidine HCL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |