NCT03742180

Brief Summary

The investigators aim to compare intranasal dexmedetomidine in a dose of 1ug.kg-1 with sublingual ketorolac in a dose of 1mg.kg-1 on postoperative behaviour in those children undergoing BMT during their PACU stay

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

November 12, 2018

Last Update Submit

September 4, 2020

Conditions

Elective Bilateral Myringotomy

Outcome Measures

Primary Outcomes (1)

  • duration of analgesia

    The duration of analgesia,define as the time to the first demand for rescue analgesic

    time from administering the study solution till the time for the first rescue analgesic] during first 24 hours

Secondary Outcomes (6)

  • Postoperative pain score

    For 24 hours after surgery

  • Heart rate

    for 2 hours after the start of surgery

  • systolic blood pressure

    for 2 hours after the start of surgery

  • Number of patients received rescue analgesics

    For 24 hours after surgery

  • Degree of sedation

    For 24 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

intranasal dexmedetomidine

EXPERIMENTAL

this group is planned for intranasal dexmedetomidine

Drug: intranasal dexmedetomidine

sublingual ketorolac

ACTIVE COMPARATOR

this group is planned for sublingual ketorolac

Drug: sublingual ketorolac

Interventions

intranasal dexmedetomidineDRUG

The patient will receive intranasal dexmedetomidine in a dose of 1ug.kg-1 in a volume of 1 ml was dripped into both nostrils using a 1-mL syringe, with the patients in the recumbent position plus 1ml sublingual 0.9% saline

intranasal dexmedetomidine
sublingual ketorolacDRUG

The patient will receive sublingual ketorolac in a dose of 0.5 mg.kg-1 in a volume of 1 ml and 1 ml intranasal saline 0.9%

sublingual ketorolac

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical status I- II.

You may not qualify if:

  • History of ketamine
  • History of NSAID
  • History of allergies
  • Any bleeding disorders
  • History of GIT bleeding
  • Those who will undergo other procedures in addition to bilateral myringotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 15, 2018

Study Start

January 1, 2018

Primary Completion

April 30, 2019

Study Completion

May 15, 2019

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

EG(1)