Tenoxicam for Intrapartum Analgesia

NCT ID: NCT02549118

Last Updated: 2015-09-15

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-03-31

Brief Summary

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The aim of this study is to assess whether tenoxicam is as effective as pethidine for analgesia during the first stage of labor.

Detailed Description

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Conditions

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Analgesia Obstetrical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tenoxicam

Intravenous administration of tenoxicam, a lyophilisate with 20 mg to be dissolved and diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.

Group Type EXPERIMENTAL

Tenoxicam

Intervention Type DRUG

Pethidine

Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.

Group Type ACTIVE_COMPARATOR

Pethidine

Intervention Type DRUG

Interventions

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Tenoxicam

Intervention Type DRUG

Pethidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Primiparity
* Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
* Maternal age between 20-30 years
* Singleton term pregnancy (37-42 weeks of gestation)
* Vertex-presenting fetus

Exclusion Criteria

* Clinical evidence of cephalopelvic disproportion
* Scarred uterus; previous cesarean section, hysterotomy or myomectomy
* Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment
* Fetal distress
* Receiving any regional or parenteral analgesia before recruitment in the study
* Known hypersensitivity to the drug family
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hamdy Bakry Mohye Soliman El Kinawy

TA

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IP-TXM

Identifier Type: -

Identifier Source: org_study_id

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