NCT01498796

Brief Summary

Our group wishes to test the novel hypothesis that intraoperative use of ketorolac in pediatric patients undergoing tonsillectomy reduces post-operative nausea and vomiting, postoperative pain scores, subsequent narcotic use, and length of hospital stay without adversely affecting post-operative bleed risk, when compared to placebo, in a double-blind, randomized controlled trial.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

December 21, 2011

Last Update Submit

March 23, 2020

Conditions

Recurrent Acute Tonsillitis

Outcome Measures

Primary Outcomes (1)

  • Pain post-tonsillectomy

    pain post-tonsillectomy

    post-operative

Study Arms (2)

Ketorolac

EXPERIMENTAL
Drug: Ketorolac

Placebo

PLACEBO COMPARATOR
Drug: Normal Saline

Interventions

KetorolacDRUG
Ketorolac
Normal SalineDRUG
Placebo

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 3yrs-15yrs who will undergo tonsillectomy or adeno-tonsillectomy for sleep disordered breathing confirmed by oximetry

You may not qualify if:

  • Severe Obstructive Sleep Apnea
  • Co-morbid disease precluding use of NSAIDS or Narcotics
  • Language/developmental/social inability to assess pain scores

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Interventions

KetorolacSaline Solution

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 23, 2011

Study Start

September 1, 2009

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

CA(1)