NCT05848505

Brief Summary

Background: Management of postoperative pain in paediatric patients undergoing tonsillectomy remains a challenge that faces anesthesiologists in their daily practice. High dose of opioids are usually necessary and are responsible for side effects like nausea, vomiting, constipation, delayed hospital discharge and more importantly respiratory depression and sleep apnea. Dexmedetomidine is a selective alpha two agonist that has an analgesic and anxiolytic effect with minimal effects on respiratory drive. Goal of the study: The aim of this study is to assess the opioid sparing effect of preoperative intranasal dexmedetomidine as part of multimodal analgesia in the paediatric population undergoing tonsillectomy. Methods: This will be a prospective, randomised, controlled, double blinded clinical trial with 50 participants who will be randomised between two groups: dexmedetomidine group and control group. The dexmedetomidine group will receive intranasal dexmedetomidine in the preoperative holding area while the other group will receive the placebo. The primary endpoint will be the total fentanyl consumption in the perioperative period. Additionally, we will look at postoperative pain scores at 10, 30 and 60 minutes after recovery as well as the time to first opioid rescue analgesic and agitation scores as secondary endpoints. Blood pressure and hart rate will also be recorded throughout the study period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
Last Updated

May 8, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

April 27, 2023

Last Update Submit

April 27, 2023

Conditions

Tonsillar Hypertrophy

Outcome Measures

Primary Outcomes (1)

  • Perioperative fentanyl consumption

    Cumulative perioperative (intraoperative and postoperative) fentanyl consumption

    From induction of anesthesia to discharge of post-anesthesia care unit (expected less than 4 hours)

Secondary Outcomes (5)

  • Postoperative pain

    From admission to discharge of post-anesthesia care unit (expected less than 3 hours)

  • Postoperative sedation

    From admission to discharge of post-anesthesia care unit (expected less than 3 hours)

  • Post-anesthesia care unit length of stay

    From admission to discharge of post-anesthesia care unit (expected less than 3 hours)

  • Bradycardia

    From induction of anesthesia to discharge of post-anesthesia care unit (expected less than 4 hours)

  • Hypotension

    From induction of anesthesia to discharge of post-anesthesia care unit (expected less than 4 hours)

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Intranasal dexmedetomidine 2 mcg/kg administered before surgery

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

Intranasal saline 0.02 mL/kg administered before surgery

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Intranasal administration Dosage 2 mcg/kg

Control groupDexmedetomidine group

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients undergoing elective tonsillectomy

You may not qualify if:

  • documented allergy to dexmedetomidine, paracetamol, ondansetron or dexamethasone
  • hepatic dysfunction
  • raised intracranial pressure or altered GCS
  • neuromuscular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Khalifa Medical City

Abu Dhabi, 51900, United Arab Emirates

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant aneshesiologist

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 8, 2023

Study Start

February 25, 2022

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

May 8, 2023

Record last verified: 2023-04

Locations

AE(1)