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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Amr A Keera, MD contact

00966544639362

amrkeera@yahoo.com

Saudi Arabia1 site
  • Doctor Soliman Fakeeh Hospital

    Jeddah, 21461

    Amr A Keera, MD, 00966544639362, amrkeera@yahoo.com

Other trials in Saudi Arabia

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.

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 groups in NCT02995304
Study groupRoleWhat they receive
Morphine and Midazolam premedicationActive comparator30 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 premedicationActive comparator30 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.

  1. Postoperative morphine requirement

    Measured: 8 hours

Secondary outcomes (3)
  1. Postoperative nonsteroidal analgesic requirements

    Measured: two days

  2. Preoperative behavior score

    1. 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

  3. 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.

  1. First posted16 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionMar 2017 (estimated)

Resources

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)
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

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.

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