Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children

NCT02995304 | Unknown DMC

• 1 other identifier: 03/IRB/2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preoperative Sedation; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine requirement

  8 hours

Secondary Outcomes (3)

• Postoperative nonsteroidal analgesic requirements

  two days

• Preoperative behavior score

  15 to 30 minutes

• Wake-up behavior scores

  30 minutes

Study Arms (2)

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.

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.

Drug: Midazolam premedication; Drug: Saline premedication (placebo)

Interventions

Morphine premedication DRUG

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

Morphine and Midazolam premedication

Midazolam premedication 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; Morphine and Midazolam premedication

Saline premedication (placebo) DRUG

30 children in midazolam only group will receive saline after midazolam

Midazolam only premedication

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Soliman Fakeeh Hospital: lead

Study Sites (1)

Doctor Soliman Fakeeh Hospital

Jeddah, 21461, Saudi Arabia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Amr A Keera, MD

  Doctor Soliman Fakeeh Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr A Keera, MD

CONTACT

00966544639362; amrkeera@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: December 16, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2017
• Last Updated: December 16, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)