Effect of Dexmedetomidine Versus Midazolam Versus a Combination of the Two as a Premedication for Children Undergoing Bilateral Myringotomy Tube Insertion

NCT02134327 | Withdrawn DMC

• 1 other identifier: JB004-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Following an obtained written consent, a child presenting for ear tube surgery will be randomized into one of three groups for receiving a premedication. One group will be the current therapy with midazolam, another group will be another drug dexmedetomidine, and the third group will be a combination of midazolam plus dexmedetomidine. Observers in the study (the investigators fellow and advance practice nurse) will not know which group each patient belongs, and will then make three separate assessments: preoperative sedation, mask acceptance, and postoperative delirium. Mask acceptance: Induction of anesthesia, or the beginning of the process for the patient to fall asleep and lose consciousness, involves placing a mask over there face, specifically the nose and mouth. The mask is connected to their anesthesia machine via tubing, or a circuit, through which their anesthetic gases flow. Some children fight the mask as it can be seen as new and frightening. Other children, sometimes depending on how sedated they are after receiving a premedication, do not fear the mask on their face and do not resist induction. How well or easily this happens can be described as "mask acceptance." Postoperative delirium can be seen in patients of any age or after any surgery and can be better defined as a mental disturbance during the recovery from general anesthesia consisting of hallucinations, delusions, and confusion manifested by moaning, restlessness, involuntary physical activity, and thrashing about in bed. It has been considered a common postanesthetic problem in children and adults since 1960. Each patient will then have a set of numbers for each scale; following conclusion of the study the investigators will be able see which drug each patient received and statistical analysis can be completed. The investigators goal is to see if there is any difference in any of the scales depending which medication was administered. The scales to be utilized include the pre-operative sedation scale, the mask acceptance scale, and the pediatric emergence delirium scale.

Conditions

Pre Operative Sedation; Mask Acceptance; Post Operative Delerium

Outcome Measures

Primary Outcomes (1)

• Post operative anesthesia emergence delerium scale

  The primary outcome will be which group of subjects have different PAED or emergence derlium scale scores.

  From beginning of when patient receives medication for assessing preoperative sedation to recovery room when postoperative delerium is assessed. This whole process takes approximately 90 minutes.

Study Arms (1)

Premedication with Midazolam

EXPERIMENTAL

Drug: Combination of Dexmedetomidine with Midazolam

Interventions

Combination of Dexmedetomidine with Midazolam DRUG

Premedication with Midazolam

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 mo-4 years
• ASA classification 1 or 2
• Vital signs, namely heart rate and blood pressure within the normal range for each patient's age group

You may not qualify if:

• Known allergies to midazolam or dexmedetomidine
• Baseline vitals outside the range listed above
• Personal or family history of malignant hyperthermia
• Genetic abnormalities predisposing to altered hemodynamics or difficult airway
• ASA physical status 3 or greater
• Known cardiac abnormalities

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

A.I. Dupont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 9, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

US (1)