Melatonin vs Midazolam in Children Undergoing Tonsillectomy

Summary

Used as a premedication to decrease anxiety (Caumo et al., 2007). Midazolam, though has several drawbacks (McCann and Kain, 2001). Hence, an alternative premedication to midazolam will definitely have a widespread appeal.

Melatonin is a hormone secreted by the pineal gland. Melatonin is different from benzodiazepines and their derivatives in that it exerts a promoting effect on sleep by amplifying day/night differences in alertness and sleep quality and displaying a modest sleep-inducing effect, quite mild as compared to that seen with benzodiazepines (Ahmad et al., 2007). Melatonin has also been reported to cause preoperative anxiolysis and an increase in levels of sedation without impairing orientation (Naguib and Samarkandi, 2000). Hence, the aim of this study is to compare the effect of oral melatonin and oral midazolam on preoperative anxiety.

Emergence delirium (ED) was first described in the literature in the early 1960s. Although often used interchangeably with emergence agitation, it is defined as a temporary dissociated state of consciousness after discontinuation of anesthesia. The characteristics that make up ED include irritability, inconsolable crying, distress and inability to cooperate (Reduque and Verghese, 2013).

Midazolam is the most prescribed oral premedication in the preoperative setting. Its benefits include preoperative anxiolysis, amnesia, relatively rapid onset and short duration of action. Although most children have anxiolysis with midazolam, up to 29% may display a paradoxical agitation response (Shin et al., 2013).

Oral melatonin doses up to 0.4 mg/kg (maximum 20 mg) are effective in reducing ED in children (age 3-7 years) (Kain et al., 2009).

AIM OF THE WORK The study aims to compare the effects of oral melatonin and oral midazolam on preoperative anxiety as a premedication in children undergoing tonsillectomy.

Conditions

• Emergence Delirium, Anesthesia
• Child
• Anxiety
• Midazolam Premedication
• Melatonin Bioavailability
• Tonsillectomy

Interventions

DRUG

Melatonin group

All patients will be subjected to a thorough medical history, physical examination, and routine preoperative investigations will be done to all children, including laboratory investigations (complete blood picture, bleeding time, prothrombin time, and partial thromboplastin time). Age, weight, and sex will be recorded. One hour before sedation, children will be transported to an isolated recovery room near the operating room. Parental presence will be allowed throughout the sedation and post-sedation period. Patients will receive 0.3 mg per kg oral melatonin in 10 ml Dextrose 10% 45 min before surgery (Maximum dose 10mg). Assessment of sedation and anxiolysis 30 min after the drug administration using Ramsay sedation scale.

DRUG

Midazolam group

All patients will be subjected to a thorough medical history, physical examination, and routine preoperative investigations will be done to all children, including laboratory investigations (complete blood picture, bleeding time, prothrombin time, and partial thromboplastin time). Age, weight, and sex will be recorded. One hour before sedation, children will be transported to an isolated recovery room near the operating room. Parental presence will be allowed throughout the sedation and post-sedation period. Patients will receive 0.3 mg per kg oral midazolam in 10 ml Dextrose 10% 45 min before surgery (Maximum dose 10mg). Assessment of sedation and anxiolysis 30 min after the drug administration using Ramsay sedation scale.

DRUG

Control group

All patients will be subjected to a thorough medical history, physical examination, and routine preoperative investigations will be done to all children, including laboratory investigations (complete blood picture, bleeding time, prothrombin time, and partial thromboplastin time). Age, weight, and sex will be recorded. One hour before sedation, children will be transported to an isolated recovery room near the operating room. Parental presence will be allowed throughout the sedation and post-sedation period. Patients will receive 10 ml pure oral Dextrose 10% 45 min before surgery. Assessment of sedation and anxiolysis 30 min after the drug administration using Ramsay sedation scale.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2026-06-30

Completion

2026-08-31