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Trial record 4 of 11 for:    tenoxicam

Hyoscine ButylBromide for Intrapartum Analgesia

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ClinicalTrials.gov Identifier: NCT02557087
Recruitment Status : Unknown
Verified September 2015 by Hamdy Bakry Mohye Soliman El Kinawy, Ain Shams Maternity Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Hamdy Bakry Mohye Soliman El Kinawy, Ain Shams Maternity Hospital

Brief Summary:
The aim of this study is to assess whether hyoscine butylbromide is as effective as pethidine for analgesia during the first stage of labor.

Condition or disease Intervention/treatment Phase
Analgesia, Obstetrical Drug: Hyoscine Drug: Pethidine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Intravenous Hyoscine ButylBromide as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial
Study Start Date : September 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyoscine
Intravenous administration of Hyoscine N-butylbromide 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: Hyoscine
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.
Drug: Pethidine



Primary Outcome Measures :
  1. 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].



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • Any medical disorders associated with pregnancy.
  • Fetal distress
  • Receiving any regional or parenteral analgesia before recruitment in the study
  • Known hypersensitivity to the drug family

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Responsible Party: Hamdy Bakry Mohye Soliman El Kinawy, TA, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02557087     History of Changes
Other Study ID Numbers: IP-HBB
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Scopolamine
Meperidine
Analgesics
Butylscopolammonium Bromide
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants