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Tenoxicam for Intrapartum Analgesia

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ClinicalTrials.gov Identifier: NCT02549118
Recruitment Status : Unknown
Verified September 2015 by Hamdy Bakry Mohye Soliman El Kinawy, Ain Shams Maternity Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Hamdy Bakry Mohye Soliman El Kinawy, Ain Shams Maternity Hospital

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

Condition or disease Intervention/treatment Phase
Analgesia Obstetrical Drug: Tenoxicam Drug: Pethidine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Intravenous Tenoxicam as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial
Study Start Date : September 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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.
Drug: Tenoxicam
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.
Drug: Pethidine



Primary Outcome Measures :
  1. 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].



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Hamdy Bakry Mohye Soliman El Kinawy, TA, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02549118     History of Changes
Other Study ID Numbers: IP-TXM
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Tenoxicam
Piroxicam
Meperidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Adjuvants, Anesthesia
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action