Preoperative SedationNCT02995304
Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children
A study testing Morphine premedication and Midazolam premedication in people with Preoperative Sedation and Postoperative Pain, run by Dr. Soliman Fakeeh Hospital at 1 site in Saudi Arabia.
Trial summary
In this double blind study, after taking an informed consent, 60 children aged between 7 and 12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly divided into three groups. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Preoperative Sedation, Postoperative Pain
- What is being tested?
- Morphine premedication and Midazolam premedication
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Dec 2016to Mar 2017
- Phase
- Interventional
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Tonsillectomy procedures in
- Children aged between 7 and 12 years old.
Who cannot join
- Bronchial asthma, obstructive sleep apnea, allergy to medications used in the study and those who are unfit for surgery or anesthesia for any reason like coagulopathy or chest infection.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Doctor Soliman Fakeeh Hospital
Jeddah, 21461
Amr A Keera, MD, 00966544639362, amrkeera@yahoo.com
About this study
In this double blind study, after taking an informed consent, 60 children aged between 7 and 12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In the second group30 children who will receive the same dose of midazolam followed by saline premedication. All groups will be compared for pain score using visual analog scale (VAS) after recovery and hourly for 8 hours and during first drinking. Heart rate (HR), blood pressure and peripheral oxygen saturation (SPO2) will be recorded before premedication, every 10 min after premedication then every 5 min during and after anesthesia. 6 point sedation score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point wake-up score will be recorded every 5 min. Time of first analgesic requirement and total morphine consumption during the first post-operative 8 hours will be recorded.
Read the detailed description
Tonsillectomy is a minor procedure but it causes sever post-operative pain. This pain is difficult to be controlled with opioids because the fear from respiratory depression in pediatric age group with postoperative oral bleeding. The World Heath Organization (WHO) guidelines clearly state that fear and lack of knowledge regarding the use of opioids in children should not be a barrier for effective analgesia (1). ). However, these procedures are usually day case and the use of oral morphine at home may be risky in some groups of this population (2). So decrease the analgesic requirements following these procedures will increase both satisfaction and safety. The trials for the use of morphine as a preemptive analgesia, in awake patient, have been limited to intramuscular (IM) or oral use which has a slow onset and unpredictable absorption. The use of preoperative IV morphine is not popular because of the unpleasant sensations following its administration. I will use small dose midazolam 0.025 gm/kg before morphine to prevent this sensation. In this double blind study, after taking an informed consent, 60 children aged between 7 and 12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In the second group30 children who will receive the same dose of midazolam followed by saline premedication. Inhalational anesthesia with sevoflurane and nitrous oxide will be used in all patients. Exclusion criteria are those with bronchial asthma, obstructive sleep apnea, allergy to medications used in the study and those who are unfit for surgery or anesthesia for any reason like coagulopathy or chest infection.
All groups will be compared for pain score using visual analog scale (VAS) after recovery and hourly for 8 hours and during first drinking. HR, blood pressure and SPO2 will be recorded before premedication, every 10 min after premedication then every 5 min during and after anesthesia. 6 point sedation score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point wake-up score will be recorded every 5 min. Time of first analgesic requirement and total morphine consumption during the first post-operative 8 hours will be recorded. Base line oxygen saturation, incidence of postoperative hypoxia, bleeding, nausea and vomiting will be recorded.
- Conditions
- Preoperative Sedation, Postoperative Pain
- Being tested
- Morphine premedication, Midazolam premedication, Saline premedication (placebo)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine premedicationDrug
30 children will 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision.
Midazolam premedicationDrug
All children who will receive 0.025 mg/kg midazolam IV as a premedication 20 to 30 min before surgical incision.
Saline premedication (placebo)Drug
30 children in midazolam only group will receive saline after midazolam
| Study group | Role | What they receive |
|---|---|---|
| Morphine and Midazolam premedication | Active comparator | 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine 20 to 30 min before surgical incision. Receives: Drug: Morphine premedication; Drug: Midazolam premedication |
| Midazolam only premedication | Active comparator | 30 children who will receive 0.025 mg/kg midazolam IV followed by saline 20 to 30 min before surgical incision. Receives: Drug: Midazolam premedication; Drug: Saline premedication (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine requirement
Measured: 8 hours
Secondary outcomes (3)
Postoperative nonsteroidal analgesic requirements
Measured: two days
Preoperative behavior score
- Behavior scores:
1 - Calm and cooperative 2 - Anxious but can be reassured 3 - Anxious and can not be reassured 4 - Crying, or resisting C. Wake-up behavior scores 1 - Calm and cooperative 2 - Not calm but could be easily calmed 3 - Not easily calmed, moderately agitated or restless 4 - Combative, excited, disoriented.
Measured: 15 to 30 minutes
Wake-up behavior scores
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative SedationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Soliman Fakeeh Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amr Aly Ismail Keera, Dr. Soliman Fakeeh Hospital
- Investigators
- Amr A Keera, MD, Principal investigator, Doctor Soliman Fakeeh Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995304
- Sponsor's protocol ID
- 03/IRB/2016
- Status last verified
- Dec 2016
- First submitted
- 2 Nov 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children
- ClinicalTrials.gov ID
- NCT02995304
- Acronym / sponsor ID
- 03/IRB/2016
- Conditions
- Preoperative Sedation, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Soliman Fakeeh HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (estimated)
- First posted
- 16 Dec 2016 (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.
In this double blind study, after taking an informed consent, 60 children aged between 7 and 12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In the second group30 children who will receive the same dose of midazolam followed by saline premedication. All groups will be compared for pain score using visual analog scale (VAS) after recovery and hourly for 8 hours and during first drinking. Heart rate (HR), blood pressure and peripheral oxygen saturation (SPO2) will be recorded before premedication, every 10 min after premedication then every 5 min during and after anesthesia. 6 point sedation score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point wake-up score will be recorded every 5 min. Time of first analgesic requirement and total morphine consumption during the first post-operative 8 hours will be recorded.
Detailed description
Tonsillectomy is a minor procedure but it causes sever post-operative pain. This pain is difficult to be controlled with opioids because the fear from respiratory depression in pediatric age group with postoperative oral bleeding. The World Heath Organization (WHO) guidelines clearly state that fear and lack of knowledge regarding the use of opioids in children should not be a barrier for effective analgesia (1). ). However, these procedures are usually day case and the use of oral morphine at home may be risky in some groups of this population (2). So decrease the analgesic requirements following these procedures will increase both satisfaction and safety. The trials for the use of morphine as a preemptive analgesia, in awake patient, have been limited to intramuscular (IM) or oral use which has a slow onset and unpredictable absorption. The use of preoperative IV morphine is not popular because of the unpleasant sensations following its administration. I will use small dose midazolam 0.025 gm/kg before morphine to prevent this sensation. In this double blind study, after taking an informed consent, 60 children aged between 7 and 12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In the second group30 children who will receive the same dose of midazolam followed by saline premedication. Inhalational anesthesia with sevoflurane and nitrous oxide will be used in all patients. Exclusion criteria are those with bronchial asthma, obstructive sleep apnea, allergy to medications used in the study and those who are unfit for surgery or anesthesia for any reason like coagulopathy or chest infection.
All groups will be compared for pain score using visual analog scale (VAS) after recovery and hourly for 8 hours and during first drinking. HR, blood pressure and SPO2 will be recorded before premedication, every 10 min after premedication then every 5 min during and after anesthesia. 6 point sedation score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point wake-up score will be recorded every 5 min. Time of first analgesic requirement and total morphine consumption during the first post-operative 8 hours will be recorded. Base line oxygen saturation, incidence of postoperative hypoxia, bleeding, nausea and vomiting will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine and Midazolam premedication | Active comparator | Drug: Morphine premedication, Drug: Midazolam premedication30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine 20 to 30 min before surgical incision. |
| Midazolam only premedication | Active comparator | Drug: Midazolam premedication, Drug: Saline premedication (placebo)30 children who will receive 0.025 mg/kg midazolam IV followed by saline 20 to 30 min before surgical incision. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Tonsillectomy procedures in
- Children aged between 7 and 12 years old.
Key exclusion criteria (1 listed)
- Bronchial asthma, obstructive sleep apnea, allergy to medications used in the study and those who are unfit for surgery or anesthesia for any reason like coagulopathy or chest infection.
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 |
|---|---|---|
| Morphine premedication30 children will 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. | Drug | Morphine and Midazolam premedication |
| Midazolam premedicationAll children who will receive 0.025 mg/kg midazolam IV as a premedication 20 to 30 min before surgical incision. | Drug | Midazolam only premedication, Morphine and Midazolam premedication |
| Saline premedication (placebo)30 children in midazolam only group will receive saline after midazolam | Drug | Midazolam only premedication |
Primary outcome
Postoperative morphine requirement
Time frame: 8 hours
3 secondary outcomes
Postoperative nonsteroidal analgesic requirements
Time frame: two days
Preoperative behavior score
Time frame: 15 to 30 minutes
Wake-up behavior scores
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Amr A Keera, MD principal investigator
Doctor Soliman Fakeeh Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine premedication and Midazolam premedication in people with Preoperative Sedation and Postoperative Pain, run by Dr. Soliman Fakeeh Hospital at 1 site in Saudi Arabia.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr A Keera, MD (00966544639362, amrkeera@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine requirement (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2016.