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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026415
Receipt No. R000030347
Scientific Title Intranasal Ketamine versus intramuscular Pethidine in labor pain analgesia.
Date of disclosure of the study information 2017/03/07
Last modified on 2017/03/06

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Basic information
Public title Intranasal Ketamine versus intramuscular Pethidine in labor pain analgesia.
Acronym Intranasal Ketamine versus intramuscular Pethidine in labor pain analgesia.
Scientific Title Intranasal Ketamine versus intramuscular Pethidine in labor pain analgesia.
Scientific Title:Acronym Intranasal Ketamine versus intramuscular Pethidine in labor pain analgesia.
Region
Africa

Condition
Condition This study was conducted in the Department of Obstetrics and Gynecology, Tanta University on patients attending the labor unit.
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to compare Ketamine when given in sub-anesthetic intra-nasal dose with intramuscular pethedine as labor analgesic
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analogue Scale (VAS)
Key secondary outcomes APGAR score at 1 and 5 minutes of neonate, pH of the cord blood, duration of labor, mode of labor, the need for rescue analgesia, the occurrence of complications like hallucination and vomiting and the overall patient satisfaction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In group A (study group 1) (53 patients) the patients received an initial dose of 0.5 mg/kg intranasal ketamine; this dose was based on previous studies regarding postoperative pain.(12) The patients then received a single repeat dose of 0.25 mg/kg intranasal ketamine after 1 hour after the initial drug administration
Interventions/Control_2 while in group B (study group 2) (52 patients) the patients received a standard 50 mg intramuscular pethidine injection. The patients then received a single repeat dose of 50 mg intramuscular pethidine injection 1 hour after the initial drug administration.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
38 years-old >=
Gender Female
Key inclusion criteria The study inclusion criteria were: Age from 18 to 38 years, with confirmed active first stage of labor with at least 2 cm cervical dilatation and at least 80% cervical effacement.
Key exclusion criteria The exclusion criteria were patients with any indication for caesarean section, patients with diabetes mellitus, hypertension, abnormal liver function tests, known cardiac or renal disease, endocrinological diseases, chronic diseases, multifetal pregnancy and also patients with history of two years infertility or more.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name ahmed elsayed elhalwagy
Organization Tanta university, faculty of medicine
Egypt
Division name obstetrics &gynecology
Zip code
Address 8 amro ebn elass street
TEL 00201202224924
Email halwagy22@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name ahmed elsayed elhalwagy
Organization Tanta university, faculty of medicine Egypt
Division name obstetrics &gynecology
Zip code
Address 8 amro ebn elass street
TEL 00201202224924
Homepage URL
Email halwagy22@yahoo.com

Sponsor
Institute Tanta university
Institute
Department

Funding Source
Organization Tanta university
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 06 Day
Last modified on
2017 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030347

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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