Caudal Versus Intravenous Magnesium Sulfate on Emergence Agitation After Sevoflurane In Children.

NCT03846284 | Unknown DMC

• 1 other identifier: MS/17.05.159
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Sevoflurane is the agent of choice for induction and maintenance of day care anesthesia in children and has a wide acceptance among pediatric anesthesiologists. Emergence agitation (EA) is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery, e.g. sevoflurane Magnesium sulfate is a non anesthetic N-methyl-D-aspartate receptor antagonist, Regional anesthetic techniques have major two benefits which are lowering anesthetic requirements intraoperatively and providing adequate postoperative pain relief. Magnesium sulfate is an adjuvant that alters the perception and duration of pain by serving as an antagonist of N-methyl-D-aspartate glutamate receptors. Caudal injection of bupivacaine with magnesium sulfate in pediatric patients after inguinoscrotal operations provided adequate postoperative analgesia without producing many side effects. Caudal block with local anesthetic with or without adjuvants may prevent emergence agitation with effective postoperative pain management.

• The oxygen saturation (SO2), heart rate (HR), and mean arterial pressure (MAP) are monitored by the observer blinded to group allocation on admission and 10 mins till discharge (0, 10, 20, 30, 40, 50, 60mints, time of discharge) from the PACU.
• Emergence agitations (Pediatric anesthesia emergency delirium scale (PAED) The presence of Emergence agitation and its severity will be measured using (PAED). The presence of Pain and its severity will be measured using FLACC scale.
• Time of first postoperative administration of fentanyl in mints
• Modified Aldrete score :- The discharge from the PACU will be measured using Modified Aldrete score.

Conditions

Emergence Agitation; Postoperative Pain

Keywords

Sevoflurane-; Emergence agitation; Magnesium sulfate; Children

Outcome Measures

Primary Outcomes (1)

• Number of Participants With sevoflurane-agitation are Assessed by Pediatric anesthesia emergency delirium scale (PAED) in 3 groups caudal versus intravenous magnesium sulfate infusions or caudal block alone

  (PAED). 1. The child makes eye contact with care giver 2. The child's actions are purposeful 3. The child is aware of his/her surroundings 4. The child is restless 5. The child is inconsolable * Items 1, 2 and 3 are scored: 4 = not at all, 3 = just a little, 2 quite a bit, 1 = very much, 0 = extremely. * Items 4 and 5 are scored: 0 = not at all, 1 = just a little, 2 = quite a bit, 3 = very much, 4 = extremely. * minimal score 0 maximal score 20 * It will be monitored on admission and every 10 mins till discharge from the PACU (0, 10, 20, 30, 40, 50, 60 mins, time of discharge). PAED score ≥ 10 fentanyl 1micg/kg I V will be given, repeated after 10 min if still agitated, with a maximum total dose of 2 micg/kg. (PAED) score ≥ 10 will be considered to be a diagnostic endpoint for agitation.

  up to 96 weeks

Secondary Outcomes (2)

• Number of Participants With Pain and its severity will be measured using FLACC in 3 groups caudal versus intravenous magnesium sulfate infusions or caudal block alone after inhalational sevoflurane anesthesia in children

  up to 96 weeks

• The discharge from the post anesthetic care unit will be measured using Modified Aldrete score after inhalational sevoflurane anesthesia in children in 3 groups

  up to 96 weeks

Study Arms (3)

Bupivacaine (B group)

PLACEBO COMPARATOR

caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline. \+ I.V injection of 10 cm saline over 10 mins then, I.V infusion 50 cm saline with rate 10-20 ml/h according to child weight.

Drug: Bupivacaine

Magnesium sulfate caudal (MC group)

EXPERIMENTAL

caudal block with bupivacaine 0.25% 1mg/kg + Magnesium sulfate 50 mg diluted in 10 cm saline. \+ I.V injection of 10 cm saline over 10 mins then, I.V infusion of 50 cm saline with rate 10-20 ml/h according to child weight.

Drug: Bupivacaine; Drug: Magnesium sulfate 50mg

Magnesium sulfate I.V (M V group)

EXPERIMENTAL

caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline. \+ I.V injection of Magnesium sulfate 30mg/kg diluted in 10 cm saline over 10 mins then, I.V infusion one ampule of Magnesium sulfate 500mg diluted in 50 cm saline with rate 10 mg/kg/h.

Drug: Bupivacaine; Drug: Magnesium sulfate 30 mg

Interventions

Bupivacaine DRUG

caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.

Also known as: local anesthetic drug

Bupivacaine (B group); Magnesium sulfate I.V (M V group); Magnesium sulfate caudal (MC group)

Magnesium sulfate 50mg DRUG

caudal block with bupivacaine 0.25% 1mg/kg plus Magnesium sulfate 50 mg diluted in 10 cm saline.

Also known as: non anesthetic N-methyl-D-aspartate receptor antagonist

Magnesium sulfate caudal (MC group)

Magnesium sulfate 30 mg DRUG

caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline. \+ I.V injection of Magnesium sulfate 30mg/kg diluted in 10 cm saline over 10 mins then, fol I.V infusion one ampule of Magnesium sulfate 500mg diluted in 50 cm saline with rate 10 mg/kg/h.

Also known as: non anesthetic N-methyl-D-aspartate receptor antagonist

Magnesium sulfate I.V (M V group)

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All participants undergoing lower abdominal surgeries

You may not qualify if:

• All participants with:-
• history of developmental delay,
• mental retardation,
• psychological disorders or
• Epilepsy which can make observational pain intensity assessment difficult,
• a known or suspect coagulopathy,
• a known allergy to any of the study drugs and
• any signs of infection at the site of the proposed caudal block.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Marwa ibrahim mohamed abdo

Al Mansurah, Egypt

Location

Related Publications (14)

• Tomal CR, Silva AG, Yamashita AM, Andrade PV, Hirano MT, Tardelli MA, Silva HC. Assessment of induction, recovery, agitation upon awakening, and consumption with the use of two brands of sevoflurane for ambulatory anesthesia. Rev Bras Anestesiol. 2012 Mar-Apr;62(2):154-72. doi: 10.1016/S0034-7094(12)70115-0.

  PMID: 22440372 BACKGROUND

• Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, Nivoche Y, Constant I, Murat I. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010 Feb;104(2):216-23. doi: 10.1093/bja/aep376. Epub 2010 Jan 3.

  PMID: 20047899 BACKGROUND

• Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.

  PMID: 15114210 BACKGROUND

• Ahuja S, Aggarwal M, Joshi N, Chaudhry S, Madhu SV. Efficacy of Caudal Clonidine and Fentanyl on Analgesia, Neuroendocrine Stress Response and Emergence Agitation in Children Undergoing Lower Abdominal Surgeries Under General Anaesthesia with Sevoflurane. J Clin Diagn Res. 2015 Sep;9(9):UC01-5. doi: 10.7860/JCDR/2015/12993.6423. Epub 2015 Sep 1.

  PMID: 26500980 BACKGROUND

• Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.

  PMID: 20705788 BACKGROUND

• Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763.

  PMID: 18372935 BACKGROUND

• Kim MS, Moon BE, Kim H, Lee JR. Comparison of propofol and fentanyl administered at the end of anaesthesia for prevention of emergence agitation after sevoflurane anaesthesia in children. Br J Anaesth. 2013 Feb;110(2):274-80. doi: 10.1093/bja/aes382. Epub 2012 Oct 26.

  PMID: 23103775 BACKGROUND

• Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.

  PMID: 23121612 BACKGROUND

• Abdulatif M, Ahmed A, Mukhtar A, Badawy S. The effect of magnesium sulphate infusion on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anaesthesia. Anaesthesia. 2013 Oct;68(10):1045-52. doi: 10.1111/anae.12380. Epub 2013 Aug 3.

  PMID: 23909742 BACKGROUND

• Stewart DW, Ragg PG, Sheppard S, Chalkiadis GA. The severity and duration of postoperative pain and analgesia requirements in children after tonsillectomy, orchidopexy, or inguinal hernia repair. Paediatr Anaesth. 2012 Feb;22(2):136-43. doi: 10.1111/j.1460-9592.2011.03713.x. Epub 2011 Oct 25.

  PMID: 22023485 BACKGROUND

• Farrag WS, Ibrahim AS, Mostafa MG, Kurkar A, Elderwy AA. Ketamine versus magnesium sulfate with caudal bupivacaine block in pediatric inguinoscrotal surgery: A prospective randomized observer-blinded study. Urol Ann. 2015 Jul-Sep;7(3):325-9. doi: 10.4103/0974-7796.152039.

  PMID: 26229319 BACKGROUND

• Benzon HA, Shah RD, Hansen J, Hajduk J, Billings KR, De Oliveira GS Jr, Suresh S. The Effect of Systemic Magnesium on Postsurgical Pain in Children Undergoing Tonsillectomies: A Double-Blinded, Randomized, Placebo-Controlled Trial. Anesth Analg. 2015 Dec;121(6):1627-31. doi: 10.1213/ANE.0000000000001028.

  PMID: 26501831 BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995 Feb;7(1):89-91. doi: 10.1016/0952-8180(94)00001-k. No abstract available.

  PMID: 7772368 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Interventions

Bupivacaine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Gehan Ad Tarabeah, MD

  Profosser of anesthesia and surgical intensive care

  STUDY CHAIR

• Hesham Ah Abdel Mohaiemn, MD

  Assisstant professor of anesthesia and surgical intensive care

  STUDY DIRECTOR

• Marwa Ib Abdo, MD

  Lecturer of anesthesia and surgical intensive care

  STUDY DIRECTOR

• Mahmoud Mo Abdel latef, Ph.D

  Resident of anesthesia and surgical intensive care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group allocation is concealed in sealed, opaque envelopes, which are not opened until participant consent has been obtained. The participants, their anesthetists, and staff providing postoperative care are blinded to group assignment. The drugs are prepared in equal aliquots with code numbers. Closed envelop will be used
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care- principal investigator

Model Details: , prospective, blind,controlled clinical trial

Study Record Dates

• First Submitted: February 10, 2019
• First Posted: February 19, 2019
• Study Start: October 8, 2017
• Primary Completion: November 15, 2018
• Study Completion: August 1, 2019
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)