Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children
Condition: Postoperative Analgesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Fentanyl; Midazolam; Bupivacaine Hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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; 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; 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 intervention name(s): sublimaze; dormicum; Bupivacaine
Intervention MeSH terms: Midazolam; Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparison of the effect of intrathecal fentanyl with the effect of intrathecal midazolam as postoperative analgesia in children undergoing infraumbilical surgery
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fentanyl versus midazolam