- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02549118
Tenoxicam for Intrapartum Analgesia
September 11, 2015 updated by: Hamdy Bakry Mohye Soliman El Kinawy, Ain Shams Maternity Hospital
Efficacy of Intravenous Tenoxicam as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial
The aim of this study is to assess whether tenoxicam is as effective as pethidine for analgesia during the first stage of labor.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
|
ACTIVE_COMPARATOR: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale
Time Frame: 4 hours
|
Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration.
Scores range from 0 [no pain] to 10 [worst possible pain].
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (ANTICIPATED)
March 1, 2016
Study Completion (ANTICIPATED)
March 1, 2016
Study Registration Dates
First Submitted
September 10, 2015
First Submitted That Met QC Criteria
September 11, 2015
First Posted (ESTIMATE)
September 15, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
September 15, 2015
Last Update Submitted That Met QC Criteria
September 11, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Meperidine
- Tenoxicam
Other Study ID Numbers
- IP-TXM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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