Suspended

Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea

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What is being tested

Morphine

+ Ibuprofen

Drug
Who is being recruted

Apnea+12

+ Nervous System Diseases

+ Neurologic Manifestations

From 1 to 10 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorHamilton Health Sciences Corporation
Study ContactLauren Kelly, MSc. BMSc. PHD candidateMore contacts
Last updated: May 27, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

Every year thousands of young children with obstructive sleep apnea undergo surgery which requires them to be prescribed pain medication. The current standard in North America is administration of opioids, mainly codeine or morphine; however in many areas of the world including Canada, nonsteroidal anti-inflammatory medications such as ibuprofen are used. Some North American surgeons are uncertain regarding the potential of ibuprofen to increase bleeding following surgery. The results of research studies have been inconclusive overall. Due to recent codeine fatalities in children following adenotonsillectomy, codeine has been removed from the formulary at many Pediatric institutions. Some surgeons have begun to use oral morphine as an alternate to codeine, which necessitates the need to find safe alternative analgesics in this treatment group. The primary objectives of this study is to assess the safety(1) and efficacy (2) of morphine and ibuprofen in children with sleep apnea. An interim analysis will be conducted after recruitment of 70 patients, to monitor both safety and efficacy

NCT01680939
Principal SponsorHamilton Health Sciences Corporation
Study ContactLauren Kelly, MSc. BMSc. PHD candidateMore contacts
Last updated: May 27, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 10 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesNeurologic ManifestationsPerceptual DisordersRespiration DisordersRespiratory Tract DiseasesSigns and SymptomsSleep Apnea SyndromesSleep Wake DisordersPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsSleep Disorders, IntrinsicDyssomniasAgnosiaSleep Apnea, Obstructive

Criteria

3 inclusion criteria required to participate
between the ages of 1-10years
diagnosed with OSAS
scheduled for tonsillectomy plus/minus adenoid removal at MUMC
5 exclusion criteria prevent from participating
any craniofacial
asthma
contraindications to analgesia
has had previous adenotonsillectomy, or
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Receives morphine for post-surgical pain

Group II

Experimental
Receives ibuprofen for post-surgical pain

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

McMaster University Medical Centre

Hamilton, CanadaOpen McMaster University Medical Centre in Google Maps
SuspendedOne Study Center