Tenoxicam for Intrapartum Analgesia

Overview

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

Full Title of Study: “Efficacy of Intravenous Tenoxicam as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2016

Interventions

  • Drug: Tenoxicam
  • Drug: Pethidine

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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].

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ain Shams Maternity Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hamdy Bakry Mohye Soliman El Kinawy, TA – Ain Shams Maternity Hospital

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