Oral Paracetamol as Preemptive Analgesia for Labor Pain

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Labor Pain

Treatments: Drug: placebo; Drug: paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT01817829

OPPALP

Personal (Other Identifier)

Details and patient eligibility

About

It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.

Full description

It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primigravida
• The gestational age between 37- 42 weeks
• Not seeking analgesia
• Singleton pregnancy
• vertex
• Spontaneous onset of labour
• 1st stage of labour (less than 5 cm)

Exclusion criteria

• Extreme of age (below18-above 40)
• Multiparous
• Multiple gestation
• Malpresentation
• Congenital or acquired pelvic abnormalities(eg. Poliomyelitis)
• Any medical disorder with pregnancy
• Induction of labour
• Advanced 1st stage > 5 cm
• Use of any other kind of analgesia before recruitment in the study
• Scared uterus
• Fetal distress

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

paracetamol

Active Comparator group

Description:

paracetamol 2 tablets1000mg PO.

Treatment:

Drug: paracetamol

placebo

Placebo Comparator group

Description:

placebo 2 tablets containing Starch PO

Treatment:

Drug: placebo