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Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children

NCT02995304 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-12-16

No results posted yet for this study

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

Interventions

DRUG

Morphine premedication

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

DRUG

Midazolam premedication

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

DRUG

Saline premedication (placebo)

30 children in midazolam only group will receive saline after midazolam

Sponsors & Collaborators

  • Dr. Soliman Fakeeh Hospital

    lead OTHER

Principal Investigators

  • Amr A Keera, MD · Doctor Soliman Fakeeh Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-03-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02995304 on ClinicalTrials.gov