NCT00725218

Brief Summary

Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress the uterine contraction pain after abortion effectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started May 2008

Shorter than P25 for phase_4 postoperative-pain

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

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 6, 2008

Status Verified

May 1, 2008

Enrollment Period

3 months

First QC Date

July 28, 2008

Last Update Submit

August 5, 2008

Conditions

Postoperative Pain

Keywords

NSAIDsPostoperative painAnalgesiaAbortion

Outcome Measures

Primary Outcomes (1)

  • VAS pain scorings

    At the end of the operation, 0,5,15,30,60min after operation

Secondary Outcomes (4)

  • Anesthetic consumptions

    At the end of the operation

  • Overall VAS satisfaction scorings with analgesia

    At the end of the study

  • Side effects

    During the whole period of the study

  • Volume of bleeding

    At the end of the study

Study Arms (2)

1

PLACEBO COMPARATOR

Saline 5 ml injection 10 min prior to propofol administration.

Drug: Saline

2

EXPERIMENTAL

Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.

Drug: Flurbiprofen Axetil

Interventions

SalineDRUG

Saline 5 ml injection 10 min prior to propofol administration.

Also known as: Ringer's solution
1
Flurbiprofen AxetilDRUG

Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.

Also known as: KaiFen
2

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA status I-II
  • Performing abortion operation (medical- or drug-induced
  • Requiring painless abortion

You may not qualify if:

  • \< 19yrs, and \>= 45yrs
  • History of central active drugs administration
  • Drug abuse
  • Hypertension
  • Diabetes
  • Any other chronic diseases
  • Allergy to the study drugs
  • Habit of over-volume alcohol drinking
  • Records of history of centrally active drug use and psychiatry
  • Any organic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

Sodium ChlorideRinger's Solutionflurbiprofen axetil

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY DIRECTOR

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

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 6, 2008

Record last verified: 2008-05

Locations

CN(1)