The Effect of Induction Technique on Postoperative Pain and Agitation
Condition: Hernia, Inguinal; Cryptorchidism
MeSH terms: Cryptorchidism; Pain, Postoperative; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to determine (a) whether patients anesthetized with
      intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia
      and undescended testis operations and (b) whether intravenous propofol anesthesia has better
      quality of recovery compared with sevofluorane anesthesia in the immediate postoperative
      period after paediatric inguinal hernia and undescended testis operations.
    

Detailed description: 
      DIFFERENT INDUCTION TECHNIQUES ON AGITATION AND POSTOPERATIVE PAIN IN CHILDREN AFTER INGUINAL
      HERNIA AND CRYPTORCHIDISM Inguinal hernia and cryptorchidism are probably the most common
      operations in the paediatric age group. Inguinal hernia is the most common indication for
      surgery in the paediatric age group and the incidence of inguinal hernia in those younger
      than 18 years old varies from 0.8 to 4.4% (1). Cryptorchidism is the most common genital
      anomaly in boys and incidence is 3.5% of all full- term infants (2).

      Advances in surgical techniques and anesthesia management most of the children can be
      discharged on the day after these kind of operations (3). Most studies of analgesia in
      pediatric day case surgery have focused on the postoperative pain risk at night, because it
      becomes the great problem for the parent. Because half of children experience clinically
      significant pain after discharge according to pain studies done for children (4).

      Volatile anesthetics can activate peripheral neurons that play important role on pain
      perception in postoperative period (3). Zhang et al reported that volatile anesthetics have
      been demonstrated to have hyperalgesic effects (5). In addition the other studies reported
      that volatile anesthetic induced pain enhancement was mediated by modulation of central
      adrenergic and cholinergic transmission (6)(7). Also modulation of 5-Hidroxytriptamine3
      receptor-mediated currents by volatile anesthetics may also play a role in their
      pronociceptin effect (8)(9).

      The recovery profile studies comparing IV propofol anesthesia with inhaled anesthetics have
      shown a better postoperative analgesia with propofol (10)(11). A recent study Tan et al shown
      that the patients anesthetized with intravenous propofol anesthesia for surgery had less pain
      than patients anesthetized with sevofluorane (12). A different study by Cheng et al
      investigating the postoperative analgesic effects of nicotine nasal spray coincidentally
      found that patients anesthetized with propofol had less postoperative pain than patients
      anesthetized with isofluorane over the postoperative 24 hours (13).

      Animal studies suggested that propofol suppressed nociceptive behavior. Propofol known to
      have nociceptive effects by activating transient receptor potential ion channel (14)(15) has
      been demonstrated to have analgesic and antihyperalgesic properties at sedative doses in a
      human pain model (16) In normal rat model, propofol has direct actions on the dorsal horn
      neurons of the spinal cord, which played an important role in the processing of sensory
      information (17) In a rat formalin model, propofol produced antinociceptive effect in a
      dose-dependent manner (18). Moreover, subhypnotic doses of propofol has been demonstrated to
      delay and weaken remifentanil induced post-infusion hyperalgesia in human (19).

      The objective of this study was to determine (a) whether patients anesthetized with
      intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia
      and undescended testis operations and (b) whether intravenous propofol anesthesia has better
      quality of recovery compared with sevofluorane anesthesia in the immediate postoperative
      period after paediatric inguinal hernia and undescended testis operations.

      MATERIAL METHODS After obtaining institutional ethics committee approval and written informed
      consent, 100 American Society of Anaesthesiologists I-II children, aged between 2 and 12
      years undergoing elective surgery for inguinal hernia repair and undescended testis were
      enrolled in the study. The study used a double-blind methodology with random allocation to
      the two groups by a computer-generated list.

      All patients' parents will be instructed on the use of the Wong-Baker Faces Pain scales for
      pain assessment before the induction of anesthesia. Both of the hands will be applied
      Eutectic Mixture of Local Anesthetics Cream (Lidocaine Hydrochloric acid, prilocaine, Astra
      Zeneca, Istanbul, Turkey) 60 minutes before the operations by the nurse. All the children
      were premedicated with midazolam hydrochloride 0.6 mg/kg orally; maximum 30 min prior to the
      surgery and we made sure that the drug was given under the tongue to avoid first liver
      passage. Patients will be monitored in the operating room. Heart rate (HR) mean arterial
      pressure (MAP), and peripheral oxygen saturation (SpO2) were recorded. Patients will be
      randomized into 2 groups using a computer-generated random number table: the first group will
      be inducted with iv propofol (Group P) and after sevofluorane inhalation will continue, the
      second group (Group S) will be inducted and continued with sevofluorane. Anesthesia was
      maintained with sevofluorane titrated to a value of 40 bispectrial index.

      I.Grup 1: Sevofluorane 8% mask induction and continue with 2% sevofluorane I.Grup 2: Propofol
      2.5mg/kg in induction and continue with 2% sevofluorane Fluid therapy was standardized during
      and after surgery. During surgery, children received lactated Ringer's solution 6 ml/ kg/ h
      whereas 5% dextrose with electrolytes was given at a rate of 4 ml/ kg/ h in the postoperative
      period. Induction of anesthesia is performed using oxygen (FiO2 0.33), nitrous oxide (FiO2
      0.66), and sevofluorane (increasing concentrations up to 8%) administered by mask. After
      sevofluorane induction intravenous cannula will be inserted. The other group propofol
      2.5mg/kg in induction and continue with 2% sevoflorane. After 0.5 mg/kg rocuronium and 1
      mcg/kg fentanyl will be applied before intubation. 5 minutes after induction heart rate,
      tension arterial, saturation will be recorded. Both of the groups will be maintained with 2%
      sevofluorane and 40% nitrous oxide. All the operations will be done with the same technique
      by the same surgeon. After spontaneous breathing , the reverse will be applied as 0.03 mg/kg
      neostigmine ve 0.01 mg/kg atropine intravenous. After reversal of airway reflexes, the
      patients will be extubated. After extubation the patients will be in postanesthesia recovery
      room. Operation time, anesthesia time will be recorded. First eye opening, first verbal
      command follow, staying time in PACU, first analgesic time, ambulation time, first oral
      intake time, extermination time will be recorded according to the anesthesia completion time.
      Completion of the surgery, 20 mg/kg rectal paracetamol will be applied as suppository form.
      However If VAS≥3 then 20 mg/kg paracetamol will be applied in intravenous form. Heart rate,
      tension arterial, saturation, respiratory rate, agitation scale, Wong-Baker Faces Pain rating
      scale for pain will be assessed and recorded. If agitation score≥4 then 1mcg/kg fentanyl will
      be applied intravenously. Wong-Baker Faces Pain rating scale will be taught to all parents
      and how to sign according to shapes of the faces of all children (No pain-smiling face to
      most pain-crying face). Transition from PACU to surgical ward was considered safe when
      patient had achieved a Modified Aldrete Score 9 for at least 10 min, and SpO2 95% with oxygen
      2 l/min or 92% without oxygen, signified recovery of physical, mental, and physiological
      function to near preanesthetic levels. Furthermore, 10-point analogue scales were used to
      measure parents' satisfaction with their child's overall anaesthetic and surgical care and
      satisfaction with their participation in decisionmaking (0 . not at all satisfied, 10 .
      extremely satisfied). All adverse events (bronchospasm, laryngospasm, desaturation,
      hypotension, bleeding, reoperation) will be recorded for postoperative 0h(PACU), 10 min, 20
      min, 30 min, 40 min, 50 min, 1h, 2h, 4h, 6h, 12h, 24h.
    

Intervention name(s): Sevofluorane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of different induction drugs and techniques; Comparison of different induction drugs and techniques
Other intervention name(s): Sevorane; pofol
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment