Dexamethasone and Post-tonsillectomy Pain in Children
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|ClinicalTrials.gov Identifier: NCT02793011|
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : June 6, 2018
The investigators will use a prospective randomized, controlled design utilizing a single preoperative dose of oral dexamethasone or placebo to achieve these specific aims:
- Specific Aim 1: To evaluate the potential for a single preoperative dose of oral dexamethasone administered the night before surgery to reduce the incidence and severity of early post tonsillectomy pain (PTP) in children
- Specific Aim 2: To prospectively evaluate differences in early PTP experience between overweight/obese children and their lean peers.
- Specific Aim 3: To determine whether circulating inflammatory markers are strongly linked to PTP severity in children and whether they could be potential contributors to the higher pain experienced by overweight/obese children following Tonsillectomy and or Adenoidectomy.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Post-tonsillectomy Pain||Drug: Dexamethasone Drug: Placebo||Phase 4|
(See brief summary as well)
The study will serve as a vehicle for a three-pronged approach (clinical observation, biological basis and therapeutic intervention) reflects the applicants professional interest in translational pediatric obesity research If the investigators find that BMI-dependent disparity exists in Post Tonsillectomy Pain (PTP) and that preoperative down regulation of inflammatory response with one preoperative dose of corticosteroids reduces PTP, our findings should ultimately lead to improved postoperative pain management of pediatric PTP especially in obese children.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
Oral dexamethasone elixir (0.5mg/ml or 4 mg/ml) mixed with Ora-sweet or simple syrup to mask the taste. Or 1 mg or 4 mg dexamethasone capsules if age appropriate
Other Name: corticosteroid
Placebo Comparator: Placebo
Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule
- Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay [ Time Frame: 0-8 hours postoperatively ]Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
- Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese). [ Time Frame: 0-8 hours postoperatively ]Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
- Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed. [ Time Frame: 0-8 hours postoperatively ]Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793011
|Contact: Olubukola Nafiu, MD||734 936 firstname.lastname@example.org|
|Contact: Monica Weber, RN BSN CCRP||734 936 email@example.com|
|United States, Michigan|
|University of Michigan C.S. Mott Children's Hospital||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Olubukola Nafiu, MD||University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology|