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Comparison of the effect of midazolam-ketamine with ketamine-propofol on post-tonsillectomy agitation in children

Comparison of the effect of midazolam-ketamine with ketamine-propofol on post-tonsillectomy agitation in children

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141009019470N92
Enrollment
150
Registered
2020-01-06
Start date
2020-02-04
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

Tonsillectomy. Chronic tonsillitis

Interventions

Intervention 1: Intervention group: The 1st group will receive ketamine 0.5 mg/kg and midazolam 0.01 mg/kg, 10 minute before the end of the surgery. Intervention 2: Intervention group: The second gr

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 15 Years

Inclusion criteria

Inclusion criteria: ASA I-II Airway class I-II Normal BMI children aged 5-15 children candidate for elective adenotonsillectomy Isoflurane based anesthesia

Exclusion criteria

Exclusion criteria: History of neuropsychiatric illness CHD URTI Seizure Drug reactions Any history of post operation complications Any complication of surgery or anesthesia that could cause agitation itself

Design outcomes

Primary

MeasureTime frame
Sedation. Timepoint: At arrival to recovery room 5 minute, 10 minute, 20 minute and on recovery room discharge. Method of measurement: Richmond Agitation & Sedation Scale (RASS).;Pain. Timepoint: At arrival to recovery room 5 minute, 10 minute, 20 minute and on recovery room discharge. Method of measurement: Objective Pain Scale (OPS).;Recover duration. Timepoint: At arrival to recovery room 5 minute, 10 minute, 20 minute and on recovery room discharge. Method of measurement: Modified Aldrete score.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRezvan Haghighat

Shiraz University of Medical Sciences

HAGHIGHAT@yahoo.com+98 71 3647 4270

Outcome results

None listed

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