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Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT03509740
Recruitment Status : Not yet recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Samy aly ashour, Cairo University

Brief Summary:
Patients presented with primary dysmenorrhea composed the study population. One gram paracetamol and 100 mg tramadol in 100 ml saline with a slow infusion were compared in ceasing dysmenorrhea in the emergency department

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: tramadol Drug: paracetamol Phase 4

Detailed Description:
Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received painkiller within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. The pain of the study patients is measured with the visual analogue scale at baseline, 15th and 30th minutes and 1 hour after study drug administration. At the end of the 60 minutes, rescue drug need is also recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Efficiencies of Intravenous Paracetamol and Intravenous Tramadol in Patients With Primary Dysmenorrhea Presented in Emergency Department
Estimated Study Start Date : April 25, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain
Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: tramadol
Intravenous 100 mg tramadol in 100 ml saline with slow infusion.
Drug: tramadol
100 mg tramadol in 100 ml saline with slow infusion

Active Comparator: paracetamol
Intravenous 1 gm paracetamol in 100 ml saline with slow infusion.
Drug: paracetamol
Intravenous 1 gm paracetamol in 100 ml saline with slow infusion
Other Name: perfalgan




Primary Outcome Measures :
  1. acute pain of dysmenorrhea measured by visual analogue scale [ Time Frame: 15 minutes ]
    Change in visual analogue scale at 15th minutes from baseline

  2. pain of dysmenorrhea measured by visual analogue scale [ Time Frame: 30 minutes ]
    Change in visual analogue scale at 30th minutes from baseline

  3. pain of dysmenorrhea measured by visual analogue scale [ Time Frame: 60 minutes ]
    Change in visual analogue scale at 60th minutes from baseline


Secondary Outcome Measures :
  1. Rescue drug need [ Time Frame: 60 minutes. ]
    the need for additional analgesic drug

  2. adverse effects. [ Time Frame: 60 minutes ]
    nausea and dizziness



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with dysmenorrhea
  • Patients over 18 years old

Exclusion Criteria:

  • denied to give inform consent
  • Renal or liver failure
  • Allergy to the study drugs
  • Receiving pain killer within the last 6 hours.
  • Physical examination findings consistent with peritoneal irritation
  • Pregnancy or patients with lactation
  • Drug addiction

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): NCT03509740


Contacts
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Contact: AHMED SAMY, MD 00201100681167 ahmedsamy8233@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AHMED SAMY, MD Cairo University

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Responsible Party: Ahmed Samy aly ashour, lecturer in obstetrics and gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT03509740     History of Changes
Other Study ID Numbers: dysmenorrhea
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tramadol
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants