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NCT Number: NCT03592537

Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

The primary aim of the present study will be to compare the analgesic effect of addition of fentanyl or midazolam to intrathecal bupivacaine by using CHEOPS pain score (Children's Hospital Eastern Ontario Pain Scale) which is based on 6 criteria: crying, facial expression, child verbal expression, torso (body position), touching or grabbing at wound and legs position. Criterion 1 is given a score of 1-3, criteria 2 and 3 are given a score of 0-2 while criteria 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ⩽ than 6 indicates adequate analgesia.

Secondary outcomes of study will be;

* is to compare the duration of postoperative analgesia. * comparative assessment regarding time for first analgesic request ,total analgesic requirements. * Hemodynamic changes or other adverse events will be recorded.

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Key information

Conditions

Postoperative Analgesia

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pediatric hospital,assiut university

Asyut, Asyut Governorate, 715715, Egypt

About this study

Spinal anesthesia (SA) in pediatrics began to be used in the late nineteenth century in multiple procedures, with the priority for high-risk and former preterm infants, for its suggested protective role compared to the development of postoperative apnea with general anesthesia (GA) . Regional anesthesia offers several advantages over general anesthesia-blunts stress response to surgery, decreases intraoperative blood loss, lowers the incidence of postoperative thromboembolic events, and provides analgesia in early postoperative period .

Spinal anesthesia has been Proposed as a means to reduce postoperative complications especially apnea and postoperative respiratory dysfunction. Prolongation of pain relief can be accomplished by various adjuvants like opioids (morphine, fentanyl, ketamine and clonidine. However, each drug has its limitations and side effects, and the need for an alternative methods and drugs always exists. Of the several opioids available for neuro-axial administration, morphine and fentanyl remain the most commonly used agents. Because of the more lipophilic nature of fentanyl, it has a more rapid onset of action than morphine.

Intrathecal fentanyl produce profound analgesia by making direct contact with the substantia-gelatinosa of the cord and it also provides cephalad extend of sensorial block. The addition of intrathecal fentanyl to spinal anesthesia improves the intraoperative and the early postoperative quality of analgesia, relieves visceral pain and attenuates sympathetic activation during surgery . The addition of intrathecal midazolam gives the best prophylaxis against intraoperative and postoperative nausea and vomiting , also various studies have shown that the analgesic effect of intrathecal bupivacaine is enhanced by intrathecal midazolam without producing significant side effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children aged 6-8years
  • undergoing infra-umbilical surgery.

Exclusion criteria

  • Children with a known history of bleeding diathesis,
  • allergy to local anesthetics,

Treatment and study plan

Fentanyl

Drug

The study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia patient care or in data collection. Children will be randomly allocated into three groups of 30 children

Other names: sublimaze

midazolam

Drug

The study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia, patient care, or in data collection. Children will be randomly allocated into three groups of 30 children

Other names: dormicum

Bupivacaine Hydrochloride

Drug

The study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia, patient care, or in data collection. Children will be randomly allocated into three groups of 30 children

Other names: Bupivacaine

Primary outcomes

  1. postoperative analgesia

    Time frame: 24 hours

    CHEOPS pain score (Children's Hospital Eastern Ontario Pain Scale) which is based on 6 criteria: crying, facial expression, child verbal expression, torso (body position), touching or grabbing at wound and legs position. Criterion 1 is given a score of 1-3, criteria 2 and 3 are given a score of 0-2 while criteria 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ⩽ than 6 indicates adequate analgesia.

Secondary outcomes

  1. to compare the duration of postoperative analgesia. comparative assessment regarding time for first analgesic request ,total analgesic requirements and any adverse effects.

    Time frame: 24hour

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine for Postoperative Analgesia in Children Undergoing Infraumbilical Surgery

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2018
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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