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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: March 2016
- 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
- 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
- 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
- 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
- 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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.