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analgesic effect of intra-nasal ketamine

Comparison of analgesic effect of intranasal ketamine versus intravenous ketamine in isolated orthopedic trauma patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015061722777N1
Enrollment
154
Registered
2015-08-12
Start date
2015-08-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fracture of upper limb , fracture of lower limb. Fracture of upper limb, level unspecified,Fracture of lower limb, level unspecified

Interventions

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
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 t
is reduced less than 13 mm (minimal clinically significant
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),
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. In

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain reduction. Timepoint: in 0, 5 ,10 , 20 and 30 min. Method of measurement: Vas Score.

Secondary

MeasureTime frame
Dizziness, nausea, pain, burning throat, amnesia, headache, pain or burning sensation. Timepoint: in 5 , 10 , 20 , 30 min. Method of measurement: physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbdolghader Pakniyat

Arak University of Medical Sciences

abdolghader.pakniyat@gmail.com+98 86 3222 2003

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026