Comparison of the effect of different doses of paracetamol with ketamine

Comparison of the effect of different doses of paracetamol with ketamine in reducing pain in limb trauma patients in the prehospital environment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210214050351N1

Enrollment

1200

Registered

2021-04-01

Start date

2021-04-21

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Limb trauma. Acute pain due to trauma

Interventions

Intervention 1: Intervention group 1: IM ketamine injection, 3 mg per kg body weight, once, if needed and no pain relief 30 mg intravenous Ketorolac?, Manufacturer: Sina Pakhsh Saba. Intervention 2: I

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with acute limb trauma Weight between 50-115 kg Systolic blood pressure over than 90 mm Hg Visual Pain Scale over than 3

Exclusion criteria

Exclusion criteria: History of drug abuse Known allergy to ketamine and acetaminophen Alcohol and psychedelics History of liver problems History of seizures GCS less than 14 Multiple trauma patient Instability of vital signs History of cardiac ischemia Pregnant Breastfeeding Blood pressure more than 110/180

Design outcomes

Primary

Measure	Time frame
Pulse rate. Timepoint: Measurement of pulse rate in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: pulseoxymeter.;Respiratory rate. Timepoint: Measure the number of breath in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: inspected respiratory rate in one minute.;Systolic and diastolic blood pressure. Timepoint: Measurement of systolic and diastolic blood pressure in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: blood pressure cuff.;Oxygen saturation rate. Timepoint: Measurement of oxygen saturation in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: pulseoxymeter.;Glasgow Coma Scale. Timepoint: Measurement of Glasgow Coma Scale at least 3 time intervals before intervention, 15 and 30 minutes after intervention and at the time of hospital delivery. Method of measurement: Patient examination.;Visual Analogue scale. Timepoint: Measurement of visual Analogue scale in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: ask ??the patient.;Age. Timepoint: at the begining. Method of measurement: ask the patient.;Sex. Timepoint: at the begining. Method of measurement: inspection.;Type of injury. Timepoint: at the begining. Method of measurement: patient examination.;Time duration from intervention till to reaching hospital. Timepoint: at the end of reaching hospital. Method of measurement: duration per hour.	—

Measure

Time frame

Pulse rate. Timepoint: Measurement of pulse rate in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: pulseoxymeter.;Respiratory rate. Timepoint: Measure the number of breath in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: inspected respiratory rate in one minute.;Systolic and diastolic blood pressure. Timepoint: Measurement of systolic and diastolic blood pressure in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: blood pressure cuff.;Oxygen saturation rate. Timepoint: Measurement of oxygen saturation in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: pulseoxymeter.;Glasgow Coma Scale. Timepoint: Measurement of Glasgow Coma Scale at least 3 time intervals before intervention, 15 and 30 minutes after intervention and at the time of hospital delivery. Method of measurement: Patient examination.;Visual Analogue scale. Timepoint: Measurement of visual Analogue scale in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: ask ??the patient.;Age. Timepoint: at the begining. Method of measurement: ask the patient.;Sex. Timepoint: at the begining. Method of measurement: inspection.;Type of injury. Timepoint: at the begining. Method of measurement: patient examination.;Time duration from intervention till to reaching hospital. Timepoint: at the end of reaching hospital. Method of measurement: duration per hour.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojgan Rahimi

Tehran University of Medical Sciences

dr.mojganrahimii@gmail.com+98 21 6119 2316

Outcome results

None listed

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