Study of Paracetamol infusion as effective pain killer during labour: Randomized Control Trial

Study of efficacy and safety of Intravenous Paracetamol Infusion as intrapartum analgesic: Randomized Control Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015161

Enrollment

300

Registered

2018-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: acetaminophen: 100 ml acetaminophen will be infused to women at active stage of labour Control Intervention1: normal saline: 100 ml normal saline will be infused to pregnant women durin

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18-35 years. 2. Primigravida and multigravida 3. The gestational age between 37- 42 weeks. 4. Patient seeking analgesia. 5. Single viable fetus. 6. Vertex presentation. 7. 1st stage of labour with cervical dilatation 3-4 cm (in active phase).

Exclusion criteria

Exclusion criteria: 1. Extreme of age (below 18-above 35). 2. Multiple gestation. 3. Malpresentation. 4. Major degree of cephalopelvic disproportion. 5. Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension. 6. Use of any other kind of analgesia before recruitment in the study 7. Scared uterus. 8. Fetal distress. 9. Antepartum hemorrhage. 10. Polyhydramnios. 11. Intra uterine infections. 12. Hypersensitivity to paracetamol.

Design outcomes

Primary

Measure	Time frame
1. To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (100 ml normal saline for injection) in women in active first stage of labour. 2. Need for a rescue additional analgesia and measuring the degree of pain relief (VAS) during the labour process.Timepoint: 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	—

Measure

Time frame

1. To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (100 ml normal saline for injection) in women in active first stage of labour. 2. Need for a rescue additional analgesia and measuring the degree of pain relief (VAS) during the labour process.Timepoint: 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

—

Secondary

Measure	Time frame
1.To document safety 2.To correlate with the duration of labour 3. To assess the adverse events recorded during the study either maternal or fetal/neonatal 4.To record the mode of deliveryTimepoint: Start of medication till delivery and neonatal assessment. Participants will be followed during this duration of labour, an expected average of 8 hours	—

Countries

India

Contacts

Public ContactPesona Grace Lucksom

Sikkim Manipal Institute of Medical sciences

pesonadoc@gmail.com7479230202

Outcome results