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Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics

A

Ain Shams University

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Emergence Delirium

Treatments

Device: infusion pump
Drug: Nalbuphine
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT04058899
Use of dexmedetomidine

Details and patient eligibility

About

The aim of the present study is to compare the effect of IV infusion 0.5 µg/kg dexmedetomidine and IV 0.1 mg/kg nalbuphine in preschool children for prevention of emergence agitation after adenotonsillectomy under sevoflurane anesthesia.

Full description

Consent will be obtained from legal guardian of children,patients will be randomized according to computer randomization to one of two groups, dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesia then 5ml of 0.9% normal saline IV ,nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia.

Enrollment

120 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children of (American Society of Anesthesiologist)ASA physical status grade I or II.
  • Aged 2-5 years
  • Undergoing elective adenotonsillectomy.

Exclusion criteria

  • History of hypersensitivity to the studied drug.
  • Refusal of the legal guardian to participate in the study.
  • Severely agitated child at induction of anesthesia
  • Occurrence of postoperative bleeding at(Post Anesthesia Care Unit) PACU

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

, Dexmedetomidine group(DEX group)
Active Comparator group
Description:
dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesa then 5ml of 0.9% normal saline IV ,
Treatment:
Drug: Dexmedetomidine
Device: infusion pump
Nalbuphine group(NAL group)
Active Comparator group
Description:
nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia.
Treatment:
Drug: Nalbuphine
Device: infusion pump

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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