CompletedNot Applicable

Intranasal Dexmedetomidine, Ketamine or Midazolam for Anxiety and Respiratory Complications in Children

Egypt148 participantsStarted 2023-02-20

Plain-language summary

This study is being done to find out which of three medications-dexmedetomidine, ketamine, or midazolam-is best at reducing anxiety and breathing problems in children having surgery to remove their tonsils and adenoids. These medicines will be given as nose drops before anesthesia. Anxiety before surgery can cause stress and lead to problems like trouble breathing during or after surgery. The study will include 148 children aged 4 to 8 years. Each child will get one of the three medicines or a placebo (saline). Researchers will observe the children for signs of anxiety before surgery and for breathing problems, such as laryngospasm, after they wake up. The goal is to find the safest and most effective medicine to help children feel calmer and breathe safely during surgery.

Who can participate

Age range

4 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Inclusion criteria * Parent or first-degree relative acceptance * Children with age ranged from 4 to8 * Body mass index is equal to or greater than 5th and not more than 85th percentiles * ASA classifications Ⅰand Ⅱ * Both sex Exclusion Criteria: * History of difficult intubation or extubation, cardiac, respiratory, renal and muscle diseases beside passive smoking and allergy to the tested drugs * History of obstructive sleep apnea (OSA). * The presence of the upper respiratory tract infection * The need to reoperation after tonsillectomy due to hemorrhage of more than 100ml of blood during surgery * Surgery duration is longer than 1.5 hour.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measurement of the vital signs mean blood pressure

Timeframe: From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)

Measurement of the heat rate

Timeframe: From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)

Measurement of respiratory

Timeframe: From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)

Scoring the incidence and severity of post-extubation laryngospasm

Timeframe: First 30 minutes after extubation

Assessment of the sedation level done by Ramsay sedation score

Timeframe: First 30 minutes post-extubation

Assessment of the sedation level done by Ramsay sedation score

Timeframe: From baseline to 20 minutes after surgery (approximately 1 hour total)

Assessment of distress associated with potentially painful event using Groningen distress scale at time of canulation.

Trial details

NCT IDNCT07072117

SponsorZagazig University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-08-20

View on ClinicalTrials.gov More Adenotonsillectomy trials

Plain-language summary

Who can participate

Age range

4 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Measurement of the vital signs mean blood pressure

Timeframe: From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)

Measurement of the heat rate

Timeframe: From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)

Measurement of respiratory

Timeframe: From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)

Scoring the incidence and severity of post-extubation laryngospasm

Timeframe: First 30 minutes after extubation

Assessment of the sedation level done by Ramsay sedation score

Timeframe: First 30 minutes post-extubation

Assessment of the sedation level done by Ramsay sedation score

Timeframe: From baseline to 20 minutes after surgery (approximately 1 hour total)

Assessment of distress associated with potentially painful event using Groningen distress scale at time of canulation.