The effect of ketamine and dexmedetomidine on preoperative sedation and intraoperative bleeding and analgesia during recovery

Comparing the effect of intranasal ketamin and intranasal dexmedetomedin versus placebo on sedation,bleeding,pain & agitation in children undergoing adenotonsilectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100518003954N9

Enrollment

Registered

2020-02-14

Start date

2018-08-23

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

Evaluation of the effect of ketamine or dexmedetomidine on placebo for preoperative relaxation& Intraoperative hemorrhage and postoperative analgesia in patients undergoing adenotonsillectomy.

Interventions

Intervention group: This study is a randomized clinical trial of children in need of elective adenotonsillectomy with ASA status I and II in Hamadan Baysat Hospital in 1397. After sufficient explanati

Eligibility

Sex/Gender

All

Age

4 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children undergoing adenotonsillectomy surgery who do not have concomitant disease.

Exclusion criteria

Exclusion criteria: Drug sensitivity to ketamine or dexmedothymidine Mental retardation ADHD Psychiatric drug use History of heart, kidney, liver disease Any pathological problems in the nose Patients who return to the operating room due to postoperative bleeding

Design outcomes

Primary

Measure	Time frame
Relaxation before intranasal injection of ketamine or dexmedetomidine in adenotonsillectomy. Timepoint: Evaluation of sedation before adenotonsillectomy in children receiving intranasal ketamine or dexmedetomidine versus placebo 15 and 30 minutes after drug administration. Method of measurement: Questionnaire according to clinical criteria.	—

Secondary

Measure	Time frame
Evaluation of the effect of medication on intraoperative bleeding. Timepoint: At the end of surgery. Method of measurement: Calculation of bleeding inside the suction bottle and bleeding medical gases.;Evaluation of the effect of medication on postoperative pain and restlessness. Timepoint: Evaluation of patient pain and restlessness at 15, 30, 45 and 60 minutes after surgery in recovery. Method of measurement: Using the standard questionnaire: Children's Hospital of Eastern Ontario pain score and Pediatric Anesthesia Emergency Delirium (PAED) scal.	—

Measure

Time frame

Evaluation of the effect of medication on intraoperative bleeding. Timepoint: At the end of surgery. Method of measurement: Calculation of bleeding inside the suction bottle and bleeding medical gases.;Evaluation of the effect of medication on postoperative pain and restlessness. Timepoint: Evaluation of patient pain and restlessness at 15, 30, 45 and 60 minutes after surgery in recovery. Method of measurement: Using the standard questionnaire: Children's Hospital of Eastern Ontario pain score and Pediatric Anesthesia Emergency Delirium (PAED) scal.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Zarei

Hamedan University of Medical Sciences

drm.zarei@yahoo.com+98 81 3264 0020

Outcome results

None listed

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