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IRCT2015061722777N1 IRCT 2015-08-12 Arak University of Medical Sciences analgesic effect of intra-nasal ketamine Comparison of analgesic effect of intranasal ketamine versus intravenous ketamine in isolated orthopedic trauma patients 2015-08-23 anticipated 154 Complete https://irct.ir/trial/19573 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 fracture of upper limb , fracture of lower limb. Intervention 1: 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. Intervention 2: 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.
public Abdolghader Pakniyat
Vali-asr Str, Emergency Medicine Department, Vali-asr Hospital
Arak Iran (Islamic Republic of) +98 86 3222 2003 abdolghader.pakniyat@gmail.com Arak University of Medical Sciences scientific Dr Ramin Parvizrad
Vali-asr Str, Emergency Medicine Department, Vali-asr Hospital
Arak Iran (Islamic Republic of) +98 86322220038 rparvizrad@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) 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. 16 years 60 years Both T10,T12 Fracture of upper limb, level unspecified,Fracture of lower limb, level unspecified Treatment - Drugs Treatment - Drugs 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. 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. Pain reduction. Timepoint: in 0, 5 ,10 , 20 and 30 min. Method of measurement: Vas Score. Dizziness, nausea, pain, burning throat, amnesia, headache, pain or burning sensation. Timepoint: in 5 , 10 , 20 , 30 min. Method of measurement: physical examination. Arak University of Medical Sciences Approved 2015-05-11 Arak University of Medical Sciences Ethic Comittee A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak University of Medical Sciences Arak Iran (Islamic Republic of)