Tenoxicam for Intrapartum Analgesia

Ain Shams Maternity Hospital

Status and phase: Unknown; Phase 2

Conditions: Obstetrical; Analgesia

Treatments: Drug: Pethidine; Drug: Tenoxicam

Study type: Interventional

Funder types: Other

Identifiers

NCT02549118

IP-TXM

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Tenoxicam

Experimental group

Description:

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.

Treatment:

Drug: Tenoxicam

Pethidine

Active Comparator group

Description:

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.

Treatment:

Drug: Pethidine