PremedicationPhase 4NCT02265822
Melatonin Premedication in Children Undergoing Surgery
A Phase 4 study testing melatonin in children premedication and midazolam in children premedication in people with Premedication and Anaesthesia, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino".
Trial summary
Melatonin has been proposed as alternative to midazolam as a premedication in procedures preceding anaesthesia induction. The objective of this prospective, randomized, double-blind study is to investigate the possible effect of melatonin premedication on the required infusion of propofol in comparison to midazolam… Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Premedication, Anaesthesia
- What is being tested?
- melatonin in children premedication and midazolam in children premedication
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the age of 5 and 14 years scheduled for elective surgery
Who cannot join
- Patients who had taken benzodiazepines, opioid drugs, or other sedative in the previous month
- Those who had sedation previously, or those with a temperament disorder, patients undergoing emergency surgery
About this study
Official title: Assessment of the Effects of Melatonin on Preoperative Anxiety and Postoperative Analgesia in Children Undergoing Surgery: a Prospective, Randomized Clinical Trial
Melatonin has been proposed as alternative to midazolam as a premedication in procedures preceding anaesthesia induction. The objective of this prospective, randomized, double-blind study is to investigate the possible effect of melatonin premedication on the required infusion of propofol in comparison to midazolam, evaluating the efficacy of oral melatonin on sedation in children undergoing surgery.
Preoperative anxiety and postoperative analgesia are also assessed in both groups.
Read the detailed description
Children between the age of 5 and 14 years scheduled for elective surgery will be prospectively enrolled between September 2012 and October 2013. A physician will perform the clinical examination for each child, and anamnestic data will be collected in the medical records. Exclusion criteria will be: patients who had taken benzodiazepines, opioid drugs, or other sedative in the previous month; those who had sedation previously, or those with a temperament disorder, patients undergoing emergency surgery. Patients will be randomly assigned to 2 groups based on whether they will receive 0.2 mg/kg (max 5 mg) oral melatonin premedication (group A) or 0.5 mg/kg (max 20 mg) oral midazolam premedication (group B) before induction anaesthesia with propofol. For elective surgery, premedication will be performed between 07:30 and 09:30 h. Approximately 40 min before the induction of general anaesthesia, patients will be transported in a quiet room in the operating suite where they will receive orally melatonin or midazolam. The melatonin will be prepared by a dedicated resident in a fixed volume of 5 ml adding water in a syringe without needle. To simulate the sweet taste of the formulation of melatonin used, midazolam will be expanded to the fixed volume with 5% dextrose. The content of the syringe, in both cases marked with a coded label, will be blindly administrated to patients by the attendant nurse, not involved in the study. The child's level of sedation will be assessed and recorded by a resident before the premedication and 40 min after the administration of melatonin or midazolam, using the University of Michigan Sedation Scale (UMSS). In the operating room, an initial bolus dose of 1 mg/kg of intravenous propofol will be administered to both groups, followed by similar bolus doses of propofol until the patient will be anesthetized. Children will be considered anesthetized when asleep and not arousable. Anaesthesia will be maintained with inhalated sevoflurane. The total dose of propofol administrated will be recorded by the anaesthetist blinded to premedication group assignment. To provide objective information on the physical condition of patients after anaesthesia, Aldrete scale will be calculated after 10 min from conclusion of anaesthesia. Preoperative anxiety and postoperative analgesia will be also assessed in both groups.
- Conditions
- Premedication, Anaesthesia
- Being tested
- melatonin in children premedication, midazolam in children premedication
- Keywords
- melatonin, midazolam, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin in children premedicationDrug
midazolam in children premedicationDrug
| Study group | Role | What they receive |
|---|---|---|
| melatonin | Experimental | 0.5 mg/kg (max 20 mg) oral melatonin premedication will be administered approximately 40 min before the induction of general anaesthesia with propofol. The melatonin will be prepared in a fixed volume of 5 ml adding water in a syringe without needle. Receives: Drug: melatonin in children premedication |
| midazolam | Active comparator | 0.5 mg/kg (max 20 mg) oral midazolam premedication will be administered approximately 40 min before the induction of general anaesthesia with propofol. The melatonin will be prepared in a fixed volume of 5 ml adding 5% dextrose in a syringe without needle. Receives: Drug: midazolam in children premedication |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of melatonin as premedicant in children undergoing elective surgery
the required infusion of propofol required during induction of general anaesthesia in both groups will be evaluated
Measured: day 1: 40-45 min after melatonin or midazolam premedication
Secondary outcomes (2)
effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery
The child's level of sedation will be assessed and recorded using the University of Michigan Sedation Scale (UMSS).
Measured: day 1: 40 min after melatonin or midazolam premedication
effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery
post procedural pain will be assessed and recorded in both groups
Measured: day 1: 3, 6, and 12 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PremedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Collaborators
- Eloisa Gitto, Lucia Marseglia, Gabriella D'Angelo, Sara Manti, Simona Montalto, Pietro Impellizzeri
- Responsible party
- Principal investigator, Carmelo Romeo MD, MSc, Azienda Ospedaliera Universitaria Policlinico
- Investigators
- Carmelo Romeo, Prof, Study chair, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265822
- Sponsor's protocol ID
- 797/2012
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Acil M, Basgul E, Celiker V, Karagoz AH, Demir B, Aypar U. Perioperative effects of melatonin and midazolam premedication on sedation, orientation, anxiety scores and psychomotor performance. Eur J Anaesthesiol. 2004 Jul;21(7):553-7. doi: 10.1017/s0265021504007094.
PubMed 15318468Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. doi: 10.1111/j.1600-079X.2006.00384.x.
PubMed 17198534Naguib M, Samarkandi AH, Moniem MA, Mansour Eel-D, Alshaer AA, Al-Ayyaf HA, Fadin A, Alharby SW. The effects of melatonin premedication on propofol and thiopental induction dose-response curves: a prospective, randomized, double-blind study. Anesth Analg. 2006 Dec;103(6):1448-52. doi: 10.1213/01.ane.0000244534.24216.3a.
PubMed 17122221Kurdi MS, Patel T. The role of melatonin in anaesthesia and critical care. Indian J Anaesth. 2013 Mar;57(2):137-44. doi: 10.4103/0019-5049.111837.
PubMed 23825812
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Melatonin on Preoperative Anxiety and Postoperative Analgesia in Children Undergoing Surgery: a Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02265822
- Acronym / sponsor ID
- 797/2012
- Conditions
- Premedication, Anaesthesia
- Keywords
- melatonin, midazolam, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Collaborators
- Eloisa Gitto, Lucia Marseglia, Gabriella D'Angelo, Sara Manti, Simona Montalto, Pietro Impellizzeri
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Melatonin has been proposed as alternative to midazolam as a premedication in procedures preceding anaesthesia induction. The objective of this prospective, randomized, double-blind study is to investigate the possible effect of melatonin premedication on the required infusion of propofol in comparison to midazolam, evaluating the efficacy of oral melatonin on sedation in children undergoing surgery.
Preoperative anxiety and postoperative analgesia are also assessed in both groups.
Detailed description
Children between the age of 5 and 14 years scheduled for elective surgery will be prospectively enrolled between September 2012 and October 2013. A physician will perform the clinical examination for each child, and anamnestic data will be collected in the medical records. Exclusion criteria will be: patients who had taken benzodiazepines, opioid drugs, or other sedative in the previous month; those who had sedation previously, or those with a temperament disorder, patients undergoing emergency surgery. Patients will be randomly assigned to 2 groups based on whether they will receive 0.2 mg/kg (max 5 mg) oral melatonin premedication (group A) or 0.5 mg/kg (max 20 mg) oral midazolam premedication (group B) before induction anaesthesia with propofol. For elective surgery, premedication will be performed between 07:30 and 09:30 h. Approximately 40 min before the induction of general anaesthesia, patients will be transported in a quiet room in the operating suite where they will receive orally melatonin or midazolam. The melatonin will be prepared by a dedicated resident in a fixed volume of 5 ml adding water in a syringe without needle. To simulate the sweet taste of the formulation of melatonin used, midazolam will be expanded to the fixed volume with 5% dextrose. The content of the syringe, in both cases marked with a coded label, will be blindly administrated to patients by the attendant nurse, not involved in the study. The child's level of sedation will be assessed and recorded by a resident before the premedication and 40 min after the administration of melatonin or midazolam, using the University of Michigan Sedation Scale (UMSS). In the operating room, an initial bolus dose of 1 mg/kg of intravenous propofol will be administered to both groups, followed by similar bolus doses of propofol until the patient will be anesthetized. Children will be considered anesthetized when asleep and not arousable. Anaesthesia will be maintained with inhalated sevoflurane. The total dose of propofol administrated will be recorded by the anaesthetist blinded to premedication group assignment. To provide objective information on the physical condition of patients after anaesthesia, Aldrete scale will be calculated after 10 min from conclusion of anaesthesia. Preoperative anxiety and postoperative analgesia will be also assessed in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin | Experimental | Drug: melatonin in children premedication0.5 mg/kg (max 20 mg) oral melatonin premedication will be administered approximately 40 min before the induction of general anaesthesia with propofol. The melatonin will be prepared in a fixed volume of 5 ml adding water in a syringe without needle. |
| midazolam | Active comparator | Drug: midazolam in children premedication0.5 mg/kg (max 20 mg) oral midazolam premedication will be administered approximately 40 min before the induction of general anaesthesia with propofol. The melatonin will be prepared in a fixed volume of 5 ml adding 5% dextrose in a syringe without needle. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the age of 5 and 14 years scheduled for elective surgery
Key exclusion criteria (2 listed)
- Patients who had taken benzodiazepines, opioid drugs, or other sedative in the previous month
- Those who had sedation previously, or those with a temperament disorder, patients undergoing emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatonin in children premedication | Drug | melatonin |
| midazolam in children premedication | Drug | midazolam |
Primary outcome
efficacy of melatonin as premedicant in children undergoing elective surgery
Time frame: day 1: 40-45 min after melatonin or midazolam premedication
the required infusion of propofol required during induction of general anaesthesia in both groups will be evaluated
2 secondary outcomes
effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery
Time frame: day 1: 40 min after melatonin or midazolam premedication
effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery
Time frame: day 1: 3, 6, and 12 hours post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
- Results publication: PubMed 15318468Acil M, Basgul E, Celiker V, Karagoz AH, Demir B, Aypar U. Perioperative effects of melatonin and midazolam premedication on sedation, orientation, anxiety scores and psychomotor performance. Eur J Anaesthesiol. 2004 Jul;21(7):553-7. doi: 10.1017/s0265021504007094.
- Results publication: PubMed 17198534Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. doi: 10.1111/j.1600-079X.2006.00384.x.
- Results publication: PubMed 17122221Naguib M, Samarkandi AH, Moniem MA, Mansour Eel-D, Alshaer AA, Al-Ayyaf HA, Fadin A, Alharby SW. The effects of melatonin premedication on propofol and thiopental induction dose-response curves: a prospective, randomized, double-blind study. Anesth Analg. 2006 Dec;103(6):1448-52. doi: 10.1213/01.ane.0000244534.24216.3a.
- Results publication: PubMed 23825812Kurdi MS, Patel T. The role of melatonin in anaesthesia and critical care. Indian J Anaesth. 2013 Mar;57(2):137-44. doi: 10.4103/0019-5049.111837.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmelo Romeo, Prof study chair
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing melatonin in children premedication and midazolam in children premedication in people with Premedication and Anaesthesia, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino".
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of melatonin as premedicant in children undergoing elective surgery (time frame: day 1: 40-45 min after melatonin or midazolam premedication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02265822, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.