Ongoing Clinical Trials for Postoperative Agitation
There is currently 1 ongoing clinical trial investigating treatments for postoperative agitation, specifically focusing on preventing agitation after anesthesia in young children. This trial is being conducted in Denmark and is testing the effectiveness of clonidine hydrochloride in preventing emergence agitation in infants aged 1 year or younger following surgery.
Clinical trial locations
Study on Preventing Agitation After Anesthesia in Children Aged 1 Year or Younger Using Clonidine Hydrochloride and Sodium Chloride
This clinical trial is investigating a condition known as emergence agitation, which can occur in children after they wake up from anesthesia. The study focuses on testing whether clonidine hydrochloride can effectively prevent this type of agitation in very young children undergoing surgery.
Who can participate:
- Children between 3 months and 12 months of age
- Children scheduled for general anesthesia using sevoflurane and an opioid pain medication
- The child’s parent or legal guardian must provide written consent for participation
Who cannot participate:
- Patients with a known allergy or sensitivity to clonidine
- Patients with a history of severe heart problems
- Patients currently taking medications that might interact negatively with clonidine
- Patients with uncontrolled high blood pressure
- Patients with severe liver or kidney disease
- Patients who are pregnant or breastfeeding
- Patients who have participated in another clinical trial recently
- Patients with a history of severe mental health disorders
- Patients unable to follow study procedures or attend follow-up visits
What the trial involves:
During surgery, children enrolled in the trial receive either clonidine hydrochloride or a placebo through an injection while under general anesthesia. Clonidine works by stimulating specific receptors in the brain, which helps to reduce nerve signals that can cause agitation. The medication is classified as an alpha-2 adrenergic agonist, meaning it has calming and sedative properties.
After the operation, the child is closely monitored in the postanesthetic care unit. Researchers assess the level of agitation using a scoring system called the Watcha score, which ranges from 1 (calm) to 4 (agitated and thrashing around). A score greater than 2 indicates significant agitation.
The study also evaluates several additional factors, including the amount of pain medication needed after surgery, the occurrence of nausea and vomiting, and potential side effects such as low blood pressure, slow heart rate, and breathing difficulties. These measurements help researchers understand both the effectiveness and safety of clonidine in this young age group.
Investigational drug:
Clonidine hydrochloride is the medication being studied in this trial. It is administered as a single dose during surgery through an intravenous route. While clonidine is primarily used to manage high blood pressure and certain pain conditions in adults, this trial is specifically evaluating its calming effects in preventing emergence agitation in infants after anesthesia. The study will also examine how the body processes clonidine when given as a single dose during surgery.
The trial is expected to continue until early 2026, and researchers hope the findings will provide valuable insights into whether clonidine can safely and effectively reduce postoperative agitation in very young children.
Summary
Currently, only one clinical trial is actively investigating treatments for postoperative agitation, with a specific focus on the pediatric population. The trial is being conducted in Denmark and targets a particularly vulnerable age group—infants between 3 and 12 months old who are undergoing surgery with general anesthesia.
The study centers on clonidine hydrochloride, a medication that has been used for other medical purposes but is now being evaluated for its potential to prevent emergence agitation in very young children. This research is important because emergence agitation can be distressing for both children and their caregivers, and effective prevention strategies could significantly improve the postoperative experience.
The trial employs a rigorous monitoring approach, using standardized scoring systems to measure agitation levels and carefully tracking potential side effects to ensure patient safety. The results from this study may provide valuable evidence to guide clinical practice in pediatric anesthesia and postoperative care.
