NCT01889979

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
Last Updated

July 9, 2013

Status Verified

July 1, 2013

Enrollment Period

7 months

First QC Date

June 26, 2013

Last Update Submit

July 7, 2013

Conditions

Pain During Labour

Keywords

Pain during labourDuration of labourApgar scoreUmbilical cord pH

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Duration of labour

    12 hours

  • Neonatal outcomes

    48 hours

  • Side effects

    48 hours

  • Requirements of oxytocin

    12 hours

Study Arms (2)

Tramadol

EXPERIMENTAL

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

Drug: Tramadol

Placebo

PLACEBO COMPARATOR

2 mL of a sterile solution SC

Drug: Placebo

Interventions

TramadolDRUG

100 mg of Tramadol was applied in the forearm SC (single dose).

Tramadol
PlaceboDRUG

2 ml of a sterile solution was applied in the forearm SC (single dose).

Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age between 37 and 40 6/7 weeks
  • Primiparous patient
  • Singleton
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, 1439 zona 9A, Panama

Location

MeSH Terms

Interventions

Tramadol

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Osvaldo Reyes, MD

    Saint Thomas Maternity Hospital

    PRINCIPAL INVESTIGATOR

  • Riggie Castillo, MD

    Saint Thomas Maternity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Research

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 1, 2013

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

July 9, 2013

Record last verified: 2013-07

Locations

PA(1)