UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026415 |
|---|---|
| Receipt number | 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 13:33:47 |
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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
| Obstetrics 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
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
halwagy22@yahoo.com
Sponsor or person
Institute
Tanta university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030347
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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