Tramadol for Labour Analgesia in Low Risk Primiparous Women

Saint Thomas Hospital (HST)

Status and phase: Completed; Phase 3

Conditions: Pain During Labour

Treatments: Drug: Placebo; Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT01889979

MHST2012-09

Details and patient eligibility

About

Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. It has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). The purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain during labour, duration of labour and neonatal outcomes.

Enrollment: 100 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age between 37 and 40 6/7 weeks
• Primiparous patient
• Singleton
• 4 to 5 cms of dilation
• Intact membranes or spontaneous rupture of membranes less than 2 hours
• Fetus in a vertex presentation
• Gynecoid pelvis by clinical examination

Exclusion criteria

• Multiparous
• Multiple pregnancies
• Any pathology
• Induction of labour with prostaglandins

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Tramadol

Experimental group

Description:

100 mg of tramadol SC (single dose) = 2 mL

Treatment:

Drug: Tramadol

Placebo

Placebo Comparator group

Description:

2 mL of a sterile solution SC

Treatment:

Drug: Placebo