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Comparison effect of submucosal injection and intravenous injection of ketamine on conscious sedation

Comparison effect of submucosal injection and intravenous injection of ketamine on conscious sedation in patients who need wound repair in emergency department

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171211037834N2
Enrollment
184
Registered
2019-11-25
Start date
2019-09-23
Completion date
Unknown
Last updated
2019-12-17

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

Conditions

sedation depth by ketamin in wound repair.

Interventions

Intervention 1: Control group: 1.5 mg/kg ketamin, rotexmedica Germany company production and with 28 gauge syringe intravenously. Intervention 2: Intervention group: 2mg/kg ketamin, rotexmedica Ger

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 8 Years

Inclusion criteria

Inclusion criteria: children who are candidates for wound repair patients without IV line before emergency department enterance parents informed consent for study participation 2-8 years old

Exclusion criteria

Exclusion criteria: ketamin sensitivity physical or mental disability immune systme diseases another necessity for IV line fixation for patient hypertension recent seziures thyroid diseases glaucoma or acute globe injury psychopathy history of airway instability and tracheal stenosis major procedures that cause posterior nasopharyngeal stimulation active lung and upper airway infection cardiovascular disease such as cardiac failure and angina pectoris porphyria major head trauma, CNS tumor, hydrocephalus

Design outcomes

Primary

MeasureTime frame
Sedation depth average. Timepoint: during procedure. Method of measurement: Ramsey score.

Secondary

MeasureTime frame
Frequency distribution of doctors satisfaction. Timepoint: after procedure. Method of measurement: very bad(0), bad(1), usual(2), good(3), very good(4).;Systolic blood pressure average. Timepoint: before, during, 5-10-15-30 min after injection. Method of measurement: Sphygmomanometer.;Heart rate average. Timepoint: before, during, 5,10,15,30 min after injection. Method of measurement: cardiac monitor.;O2 saturation percent average. Timepoint: before, during, 5-10-15-30 min after injection. Method of measurement: pulse oximetry.;Respiratory rate average. Timepoint: before, during, 5-10-15-30 min after injection. Method of measurement: respiration in 1 minute.;Admition duration average. Timepoint: during discharge. Method of measurement: admition duration in minute.;Sedation duration average. Timepoint: during sedation. Method of measurement: since the patient dose not obey orders until the patient obeys orders again.;Sedation onset average. Timepoint: drug administration. Method of measurement: from drug administration to disobedience onset.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Ahmadpour

Esfahan University of Medical Sciences

dr.ahmadpour.ma@gmail.com+98 31 3651 5338

Outcome results

None listed

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