Tramadol for Labour Analgesia in Low Risk Primiparous Women

Tramadol for Labour Analgesia in Low Risk Primiparous Women. Double Blind, Randomized, Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Pain During Labour
• Intervention / Treatment: Drug: Tramadol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Panama
  • Panama, Panama, 1439 zona 9A
    • Saint Thomas Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tramadol; 100 mg of tramadol SC (single dose) = 2 mL	Drug: Tramadol; 100 mg of Tramadol was applied in the forearm SC (single dose).
Placebo Comparator: Placebo; 2 mL of a sterile solution SC	Drug: Placebo; 2 ml of a sterile solution was applied in the forearm SC (single dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during labour	Pain during labour was evaluated using the Visual Analogue Scale during the first six hours after the application of the drug (tramadol or placebo).	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of labour	The duration of labour in minutes (all patients were admitted with 4-5 cms of dilation), comparing both groups.	12 hours
Neonatal outcomes	Apgar score at minute one and five and umbilical cord pH were evaluated and compared between both groups.	48 hours
Side effects	Maternal respiratory depression, headaches, nausea and dizziness were evaluated in both groups.	48 hours
Requirements of oxytocin	Maximum dose of oxytocin (mU/min) required to have regular uterine contractions.	12 hours

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama
• Investigators: Principal Investigator: Osvaldo Reyes, MD, Saint Thomas Maternity Hospital; Principal Investigator: Riggie Castillo, MD, Saint Thomas Maternity Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: June 28, 2013
• First Posted (Estimate): July 1, 2013

Study Record Updates

• Last Update Posted (Estimate): July 9, 2013
• Last Update Submitted That Met QC Criteria: July 7, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Pain during labour; Duration of labour; Apgar score; Umbilical cord pH
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: MHST2012-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No