Flurbiprofen Axetil for Uterine Contraction Pain

NCT ID: NCT00725218

Last Updated: 2008-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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NSAIDs Postoperative pain Analgesia Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Saline 5 ml injection 10 min prior to propofol administration.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline 5 ml injection 10 min prior to propofol administration.

2

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

Group Type EXPERIMENTAL

Flurbiprofen Axetil

Intervention Type DRUG

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

Interventions

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Saline

Saline 5 ml injection 10 min prior to propofol administration.

Intervention Type DRUG

Flurbiprofen Axetil

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

Intervention Type DRUG

Other Intervention Names

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Ringer's solution KaiFen

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \< 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Maternal and Child Health Hospital

Principal Investigators

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XiaoFeng Shen, MD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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M089732

Identifier Type: -

Identifier Source: secondary_id

NMU-MZ203

Identifier Type: -

Identifier Source: org_study_id