The use of intranasal route for delivering medication such as ketamine, provides an efficient and relatively painless way for analgesia delivery. In a double-blind randomized controlled trial study, patients with age between 16 to 60 years, who are present by isolated orthopedic trauma and pain VAS score of more than 50 mm, enrolled in the study, considering inclusion and exclusion criteria. The sample size estimates 77 patients in each group based on Alpha 5% and 90% power and 10% as loss potential. Patients will divide in two groups randomly. Group A and B will be treated with nasal ketamine- intravenous sterile water and intravenous low dose ketamine- nasal sterile water respectively. Patients & researchers and analysts will be blind to groups of study. The VAS reduction and complications at time 0, 5, 10, 20 and 30 minute will recorded and then the difference between these values is evaluated by statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061722777N1
Registration date:2015-08-12, 1394/05/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-12, 1394/05/21
Registrant information
Name
Abdolghader Pakniyat
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 344 9177
Email address
a.pakniyat@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of intranasal ketamine versus intravenous ketamine in isolated orthopedic trauma patients
Public title
analgesic effect of intra-nasal ketamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with isolated trauma with fracture in the upper or lower extremities; aged between 16 and 60 years old; with Visual Analogue Scale pain score of more than 50 mm.
Exclusion criteria: Patient’s refusal to participate in the study; having an underlying medical condition such as migraine, cardiac ischemia, schizophrenia, addiction, history of allergy to opiates or ketamine, head trauma or loss of consciousness; blood pressure of more than 180/100; vital signs Instability before and during the study; pregnancy; nasal deformity or injury which prevents nasal medication administration; any inability to express their pain during the study; consumption of high doses of analgesics within the last 4 hours, such as tramadol, methadone and opiates; presence of other trauma.
Age
From 16 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences Ethic Comittee
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak University of Medical Sciences
City
Arak
Postal code
3819693345
Approval date
2015-05-11, 1394/02/21
Ethics committee reference number
Ir.arakmu.rec.1394.25
Health conditions studied
1
Description of health condition studied
fracture of upper limb , fracture of lower limb
ICD-10 code
T10,T12
ICD-10 code description
Fracture of upper limb, level unspecified,Fracture of lower limb, level unspecified
Intervention1 (case group): In Group A, patients receive a dose of 0.4 mg / kg intranasal ketamine initially by atomizer (dividing the dose in half and administering each half-dose per each nostril), and the same volume of intravenous Sterile water as placebo. Drugs’ dose are calculated based on patient weight, intravenous and intranasal will be labeled as v (vein) and n (nasal) for group (A) respectively. VAS score and complication such as dizziness, nausea, pain, sour throat, amnesia, headache, pain or inflammation inside the nose will be recorded at times of 5, 10, 20 and 30. Patients whose VAS scale in T10; is reduced less than 13 mm (minimal clinically significant change noticeable by patients), were excluded from the study and routine analgesia administration and monitoring will be performed, also in the cases with noticeable pain reduction (more than 13 mm), but without acceptable pain reduction (at least 30 mm), a dose of 0.4 mg / kg intranasal ketamine (up to total dose of 0.8 mg /kg) should be re-injected at T10 and T20, along with placebo. If acceptable pain reduction is not achieved at T30, 0.05 mg / kg of intravenous morphine with routine monitoring as V (m) will be administrated in order to control the pain. During investigation, Patients will be monitored regarding vital signs and consciousness. They will be discharged only when they fully recover their consciousness.
Category
Treatment - Drugs
2
Description
Control group: in group (B), patients receive 0.2 mg / kg ketamine intravenously initially and the same volume of nasal sterile water as placebo. Drugs’ dose are calculated based on patient weight. Intravenous and intranasal will be labeled as v (vein) and n (nasal) for group (B) respectively. VAS score and complication such as dizziness, nausea, pain, sour throat, amnesia, headache, pain or inflammation inside the nose will be recorded at times of 5, 10, 20 and 30. Patients whose VAS scale in T10; is reduced less than 13 mm (minimal clinically significant change noticeable by patients), were excluded from the study and routine analgesia administration and monitoring will be performed, also in the cases with noticeable pain reduction (more than 13 mm), but without acceptable pain reduction (at least 30 mm) at T10, T20 and T30, 0.1 mg / kg ketamine (up to total dose of 0.4 mg /kg) should be re-injected intravenously along with intranasal placebo. If acceptable pain reduction is not achieved by T30, 0.05 mg / kg of intravenous morphine with routine monitoring as V (m) will be administrated in order to control the pain. During investigation, Patients will be monitored regarding vital signs and consciousness. They will be discharged only when they fully recover their consciousness.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Emergency Trauma Center
Full name of responsible person
Abdolghader Pakniyat
Street address
Vali-asr Str, Emergency Medicine Department, Vali-asr Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Abdolghader Pakniyat
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak University of Medical Sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Abdolghader Pakniyat
Position
MD , Emergency Medicine Resident
Other areas of specialty/work
Street address
Vali-asr Str, Emergency Medicine Department, Vali-asr Hospital
City
Arak
Postal code
Phone
+98 86 3222 2003
Fax
Email
abdolghader.pakniyat@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ramin Parvizrad
Position
Assistant Professor
Other areas of specialty/work
Street address
Vali-asr Str, Emergency Medicine Department, Vali-asr Hospital
City
Arak
Postal code
Phone
+98 86322220038
Fax
Email
rparvizrad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Abdolghader Pakniyat
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)