NCT01535287

Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia

Completed Phase 4 Results posted Last updated 9 July 2018

What this trial tests

Phase 4 trial testing Dexmedetomidine in Myringotomy in 140 participants. Completed in 8 October 2013.

Timeline

4 January 2011

Primary endpoint
8 October 2013

8 October 2013

Quick facts

Lead sponsor	Martin Mueller
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	140
Start date	4 January 2011
Primary completion	8 October 2013
Estimated completion	8 October 2013
Sites	1 location across United States

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →

Conditions studied

• Myringotomy — all drugs for Myringotomy →

Sponsor

Martin Mueller

Who can join

Adults 1 to 10, any sex, with Myringotomy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area). Primary · Participants will be followed for the duration of first PACU recovery step, an expected average visit of 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.

The aim/measurement of the study is to determine whether or not a single IM injection of Dexmedetomidine will reduce the severity of Emergent Agitation (EA) in children undergoing Bilateral Myringotomy with/without tubes under general anesthesia. We used the only validated scale to assess the severity of post operative emergence delirium in pediatrics. This Pediatric Anesthesia Emergence Delirium (PAED) scale is a composite score of the following items: 1. Makes eye contact with caregiver. 2. Child's actions are purposeful. 3. Child aware of his/her surroundings. 4. The child is restless. 5.

Group	Value	95% CI
Dexmedetomidine	7	± 6
Placebo	8	± 6

Duration of Stay in PACU Secondary · Participants will be followed immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.

Duration of stay in the PACU (Post-Op Area) until discharge criteria are met based on modified PADSS score: level of consciousness, physical activity, hemodynamic stability, respiratory stability, oxygen saturation status, post-operative pain, and post-operative emetic symptoms. Duration of time will be measured in total minutes participate is in PACU until discharged.

Group	Value	95% CI
Dexmedetomidine	21	± 9
Placebo	17	± 7

Respiratory Complications Peri-Operative Secondary · Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

Postoperative adverse respiratory events: moderate to severe coughing, oxygen desaturation (SPO2 \<90%), breath holding, bronchospasm, aspiration, stridor and/or laryngospasm during PACU duration to discharge. The adverse respiratory events and the adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered. Measurement will be obtained by "yes"/"no" to each possible adverse respiratory event by anesthesia staff.

Group	Value	95% CI
Dexmedetomidine	0	± 0
Placebo	0	± 0

Hemodynamic Instability Secondary · Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

Postoperative adverse hemodynamic events: bradycardia-a decrease in heart rate, hypotension-a decrease in systolic blood pressure (both determined as a 30% decrease from baseline) during PACU duration to discharge. The adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered.Measurement will be obtained by "yes"/"no" to each possible adverse respiratory event by anesthesia staff.

Group	Value	95% CI
Dexmedetomidine	0	± 0
Placebo	0	± 0

Post-Operative Behavioral Disturbances Secondary · Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

Behavioral disturbances analyzed are: sleep disturbances, anxiety, eating disturbances. These post-operative behavioral disturbances are not considered an adverse event. Data regarding postoperative behavioral disturbances will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any "other adverse event" (not including serious) will also be documented by the telephone interview. Measurement will be obtained by "yes"/"no" to each possible AE by staff based on parent(s) response. "Other adverse events" (not including serious) reported immediately post-operativ

Group	Value	95% CI
Dexmedetomidine	9
Placebo	10

Muscle Pain Secondary · Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

Postoperative muscle pain or swelling at the drug injection site. The duration of the stay in the PACU will be retrospectively documented by the research team using EPIC. Data regarding postoperative muscle pain or swelling will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any adverse event will also be documented by the telephone interview. Measurement will be obtained by "yes"/"no" by staff based on parent(s) response.

Group	Value	95% CI
Dexmedetomidine	0
Placebo	0

Sponsor's own description

The investigators are inviting your child to participate in this research study because your child is having myringotomy (putting a tiny incision in the eardrum with or without tube insertion) under general anesthesia.

The purpose of this study is to determine whether a single injection of Dexmedetomidine (study medication) decreases the frequency of awaking from anesthesia frightened or agitated in children having myringotomy surgery as compared to those children who receive placebo (sterile saltwater).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Publication bias in pediatric emergence delirium: a cross-sectional analysis of ClinicalTrials.gov and ClinicalTrialsRegister.eu.
   Meyburg J, Ries M. · · 2020 · cited 5× · PMID 33060081 · DOI 10.1136/bmjopen-2020-037346