UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intranasal Ketamine versus intramuscular Pethidine in labor pain analgesia.
Title of the study (Brief title)	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	ahmed elsayed elhalwagy
Organization	Tanta university, faculty of medicine Egypt
Division name	obstetrics &gynecology
Address	8 amro ebn elass street
TEL	00201202224924
Email	halwagy22@yahoo.com

Public contact
Name of contact person	ahmed elsayed elhalwagy
Organization	Tanta university, faculty of medicine Egypt
Division name	obstetrics &gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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