Tenoxicam for Intrapartum Analgesia

Phase 2

• Conditions: Analgesia; Obstetrical
• Interventions: Drug: Tenoxicam; Drug: Pethidine

• Registration Number: NCT02549118
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-15
• Last Update Posted: 2015-09-15
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenoxicam	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.
Pethidine	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.

Primary Outcome Measures

Name	Time	Method
The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale	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 \[worst possible pain\].