Tenoxicam for Intrapartum Analgesia

NCT02549118 | Unknown Phase 2 DMC

• 1 other identifier: IP-TXM
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Analgesia; Obstetrical

Outcome Measures

Primary Outcomes (1)

• The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale

  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

Study Arms (2)

Tenoxicam

EXPERIMENTAL

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

Pethidine

ACTIVE COMPARATOR

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

Interventions

Tenoxicam DRUG

Tenoxicam

Pethidine DRUG

Pethidine

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

MeSH Terms

Conditions

Agnosia

Interventions

tenoxicam; Meperidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: TA

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 15, 2015

Record last verified: 2015-09