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Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children

NCT ID: NCT02995304

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Brief Summary

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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

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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

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Preoperative Sedation Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Morphine and Midazolam premedication

30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine 20 to 30 min before surgical incision.

Group Type ACTIVE_COMPARATOR

Morphine premedication

Intervention Type DRUG

30 children will 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision.

Midazolam premedication

Intervention Type DRUG

All children who will receive 0.025 mg/kg midazolam IV as a premedication 20 to 30 min before surgical incision.

Midazolam only premedication

30 children who will receive 0.025 mg/kg midazolam IV followed by saline 20 to 30 min before surgical incision.

Group Type ACTIVE_COMPARATOR

Midazolam premedication

Intervention Type DRUG

All children who will receive 0.025 mg/kg midazolam IV as a premedication 20 to 30 min before surgical incision.

Saline premedication (placebo)

Intervention Type DRUG

30 children in midazolam only group will receive saline after midazolam

Interventions

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Morphine premedication

30 children will 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision.

Intervention Type DRUG

Midazolam premedication

All children who will receive 0.025 mg/kg midazolam IV as a premedication 20 to 30 min before surgical incision.

Intervention Type DRUG

Saline premedication (placebo)

30 children in midazolam only group will receive saline after midazolam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Tonsillectomy procedures in
* Children aged between 7 and 12 years old.

Exclusion Criteria

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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Soliman Fakeeh Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Amr Aly Ismail Keera

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr A Keera, MD

Role: PRINCIPAL_INVESTIGATOR

Doctor Soliman Fakeeh Hospital

Locations

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Doctor Soliman Fakeeh Hospital

Jeddah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Central Contacts

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Amr A Keera, MD

Role: CONTACT

Phone: 00966544639362

Email: [email protected]

Facility Contacts

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Amr A Keera, MD

Role: primary

Other Identifiers

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03/IRB/2016

Identifier Type: -

Identifier Source: org_study_id