NCT03509740

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

April 17, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2018

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

April 17, 2018

Last Update Submit

June 14, 2020

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (3)

  • acute pain of dysmenorrhea measured by visual analogue scale

    Change in visual analogue scale at 15th minutes from baseline

    15 minutes

  • pain of dysmenorrhea measured by visual analogue scale

    Change in visual analogue scale at 30th minutes from baseline

    30 minutes

  • pain of dysmenorrhea measured by visual analogue scale

    Change in visual analogue scale at 60th minutes from baseline

    60 minutes

Secondary Outcomes (2)

  • Rescue drug need

    30 minutes.

  • adverse effects.

    60 minutes

Study Arms (2)

tramadol

EXPERIMENTAL

Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes.

Drug: tramadol

paracetamol

ACTIVE COMPARATOR

Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes.

Drug: paracetamol

Interventions

tramadolDRUG

100 mg tramadol in 100 ml saline with slow infusion

tramadol
paracetamolDRUG

Intravenous 1 gm paracetamol in 100 ml saline with slow infusion

Also known as: perfalgan
paracetamol

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with moderate to severe primary dysmenorrhea and visual analog scale (VAS) pain scores ≥40
  • Patients over 18 years old

You may not qualify if:

  • denied to give inform consent, irregular menstrual cycles, known or suspected secondary dysmenorrhea
  • 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 or Alcohol Abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aljazeerah Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

TramadolAcetaminophen

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsAcetanilidesAnilidesAmidesAniline Compounds

Study Officials

  • AHMED SAMY, MD

    Cairo University

    STUDY DIRECTOR

  • mahmoud alalfy, MD

    National Research Center

    PRINCIPAL INVESTIGATOR

  • Ahmed Ali, mbbch

    faculty of medicine al-azhar university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
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
lecturer in obstetrics and gynecology

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 26, 2018

Study Start

April 25, 2018

Primary Completion

October 1, 2018

Study Completion

October 20, 2018

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

EG(1)