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Trial record 20 of 450 for:    TRAMADOL

Tramadol for Labour Analgesia in Low Risk Primiparous Women

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ClinicalTrials.gov Identifier: NCT01889979
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : July 9, 2013
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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.

Condition or disease Intervention/treatment Phase
Pain During Labour Drug: Tramadol Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tramadol for Labour Analgesia in Low Risk Primiparous Women. Double Blind, Randomized, Controlled Trial.
Study Start Date : October 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

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).




Primary Outcome Measures :
  1. Pain during labour [ Time Frame: 6 hours ]
    Pain during labour was evaluated using the Visual Analogue Scale during the first six hours after the application of the drug (tramadol or placebo).


Secondary Outcome Measures :
  1. Duration of labour [ Time Frame: 12 hours ]
    The duration of labour in minutes (all patients were admitted with 4-5 cms of dilation), comparing both groups.

  2. Neonatal outcomes [ Time Frame: 48 hours ]
    Apgar score at minute one and five and umbilical cord pH were evaluated and compared between both groups.

  3. Side effects [ Time Frame: 48 hours ]
    Maternal respiratory depression, headaches, nausea and dizziness were evaluated in both groups.

  4. Requirements of oxytocin [ Time Frame: 12 hours ]
    Maximum dose of oxytocin (mU/min) required to have regular uterine contractions.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889979


Locations
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Panama
Saint Thomas Maternity Hospital
Panama, Panama, 1439 zona 9A
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
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Principal Investigator: Osvaldo Reyes, MD Saint Thomas Maternity Hospital
Principal Investigator: Riggie Castillo, MD Saint Thomas Maternity Hospital

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Responsible Party: Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01889979     History of Changes
Other Study ID Numbers: MHST2012-09
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Pain during labour
Duration of labour
Apgar score
Umbilical cord pH
Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents