Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial
Overview
- Phase
- Phase 3
- Intervention
- (1) Paracetamol injection
- Conditions
- Labor Pain
- Sponsor
- Ain Shams University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour.
Detailed Description
Comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo (intravenous sterile water infusion) in parturient women in active first phase of labour and requiring intrapartum analgesia.
Investigators
Ahmed Elsayed Hassan Elbohoty
Lecturer in OB GYN
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •Age between 18-35 years.
- •Primigravida.
- •The gestational age between 37- 42 weeks.
- •Patient seeking analgesia.
- •Single viable fetus.
- •Vertex presentation.
- •Spontaneous onset of labor.
- •1st stage of labor with cervical dilatation 3-4 cm ( in active phase).
Exclusion Criteria
- •Extreme of age (below 18-above 35).
- •Multiparity.
- •Multiple gestation.
- •Malpresentation.
- •Major degree of cephalopelvic disproportion.
- •Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia.
- •Induction of labor.
- •Cervical dilatation exceeds exceeding 4 cm.
- •Use of any other kind of analgesia before recruitment in the study.
- •Scared uterus.
Arms & Interventions
(1) Active (Paracetamol) arm: n=60
(Paracetamol)
Intervention: (1) Paracetamol injection
(2) Placbo (Sterile water) arm: n=60
Sterile water
Intervention: Sterile water
Outcomes
Primary Outcomes
To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
Time Frame: Start of medication till end of first stage of labour. Participants will be followed for the duration of labour, an expected average of 8 hours.
By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process.
Secondary Outcomes
- To document safety(Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours.)
- To correlate with the duration of labor(Start of medication till end of second stage of labour. Participants will be followed for the duration of labour, an expected average of 9 hours.)