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Effect of intranasal dexmedetomidine versus intranasal ketamine on emergence agitation after sevoflurane anesthesia in myringotomy patients: a randomized clinical trial.

Intranasal dexmedetomidine versus intranasal ketamine for prevention of emergence agitation after sevoflurane anesthesia in pediatric patients undergoing myringotomy : a randomized clinical trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000921482
Enrollment
90
Registered
2016-07-11
Start date
2016-02-02
Completion date
2016-05-26
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

None listed

Brief summary

The aim of this prospective randomized study is to compare the effect of intranasal dexmedetomidine and intranasal ketamine for prevention of emergence agitation after sevoflurane anesthesia in pediatric patients scheduled for myringotomy operations.

Interventions

Preoperatively, all patients will be assessed by detailed medical and surgical history, complete clinical examination and routine laboratory investigations and will be allocated randomly into two groups; Group I (intranasal ketamine group = 45 children): Children of this group will receive ketamine intranasal in a dose 5 mg/kg. Group II (Intranasal dexmedetomidine group = 45 children): Children of this group will receive dexmedetomidine intranasal in a dose 1 microgram/kg. A preoperative fast

Preoperatively, all patients will be assessed by detailed medical and surgical history, complete clinical examination and routine laboratory investigations and will be allocated randomly into two groups; Group I (intranasal ketamine group = 45 children): Children of this group will receive ketamine intranasal in a dose 5 mg/kg. Group II (Intranasal dexmedetomidine group = 45 children): Children of this group will receive dexmedetomidine intranasal in a dose 1 microgram/kg. A preoperative fasting period of 6 hours. No premedication will be taken. Induction of general anesthesia will done 15 minutes after study drug administration with sevoflurane which will be titrated with increments of 1% at each breath up to 8% in oxygen 100%. Once an appropriate depth of anesthesia will be obtained an IV cannula and a suitable laryngeal mask will be inserted (its position will be confirmed by capnography) and sevoflurane concentration will be reduced to an end tidal concentration of 3% in 100% oxygen. Spontaneous breathing will be allowed provided ETCO2 remained below 50 mm Hg; if ETCO2 exceeded 50 mm Hg, the patient will be excluded from the study and ventilation will be assisted. No muscle relaxant or narcotic will be administered during the procedure. The patients will be monitored continuously for heart rate, oxygen saturation, respiratory rate, end tidal CO2 and mean arterial blood pressure. Sevoflurane will be discontinued immediately after insertion of the T-tube, and the laryngeal mask will be removed 60 seconds later and the patient will be transported to the post-anesthesia care unit (PACU) in a quiet and warm environment without any stimulus. Parents will be allowed to be at the child’s bedside in the PACU.

Sponsors

Hoda Alsaid Ahmed Ezz
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

Patients prepared to unilateral or bilateral myringotomy Both sexes, age from 3 to 6 years old. ASA physical status I or II.

Exclusion criteria

a -Parent's refusal. b- Preoperative agitation (e.g. cerebral palsy, agitation…etc). c - Children with allergy to ketamine, dexmedetomidine. d - Aberrant nasal deformity or nasal trauma. e - Acute (e.g. running nose or upper respiratory tract infection) or chronic nasal problems. f -Mental retardation, physical developmental delay, or neuromuscular disease. g - Patients under treatment with sedatives or anticonvulsants. h - Respiratory and cardiovascular diseases.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026