Failed Moderate Sedation During ProcedurePhase 4NCT02127489

The Effects of Single-dose Rectal Midazolam Application on Post-operative Recovery

A Phase 4 study testing 1 mL/kg bupivacaine 0.25%. in people with Failed Moderate Sedation During Procedure, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aimed to compare the efficiency of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional analgesics, postoperative recovery, sedation, and to find out its adverse effects in children having lower abdominal surgery. Read more about this study

Who is it for?: Ages 2 to 10 years
Conditions the study is for: Failed Moderate Sedation During Procedure
What is being tested?: 1 mL/kg bupivacaine 0.25%.
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Jun 2005to Jun 2006
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

children having lower abdominal surgery

Who cannot join

Children with significant respiratory system, circulatory system, liver, and kidney function disorder, history of allergy to the drugs to be studied, those who received analgesic medication before the operation, and those for whom caudal anesthesia is contraindicated

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Karadeniz Technical University Faculty of Medicine
Trabzon, 61080

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Single-dose Rectal Midazolam Application on Post-operative Recovery, Sedation, and Analgesia in Children Given Caudal Anesthesia Plus Bupivacaine

Read the detailed description

Summary Background: This study aimed to compare the efficiency of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional analgesics, postoperative recovery, sedation, and to find out its adverse effects in children having lower abdominal surgery.

Methods: 40 children between 2 and 10 years of American Society of Anesthesiologist (ASA) I-II stages were randomized and applied caudal anesthesia under general anesthesia. Patients were applied caudal block in addition with saline and 1milliliter/kilograms (mL/kg) bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5 milliliter (mL) saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline. Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.

Conditions: Failed Moderate Sedation During Procedure
Being tested: 1 mL/kg bupivacaine 0.25%.
Keywords: Bupivacaine, caudal, rectal midazolam, children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1 mL/kg bupivacaine 0.25%.Drug
Also called AstraZeneca Marcaine
40 children between 2 and 10 years of ASA I-II were randomized and they received caudal anesthesia under general anesthesia. Patients underwent the application of caudal block in addition with saline and 1 mL/kg bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5mL saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline. Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.

Study groups in NCT02127489
Study group	Role	What they receive
Midazolam	Active comparator	1 mL/kg bupivacaine 0.25%. Receives: Drug: 1 mL/kg bupivacaine 0.25%.
saline	Placebo comparator	5mL rectal saline Receives: Drug: 1 mL/kg bupivacaine 0.25%.

What is being measured

The primary outcome is the main question the study is designed to answer.

Sedation scale and postoperative pain scale (CHIPPS)
Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Jun 2006

First posted30 Apr 2014 (estimated)
Study startJun 2005
Primary completionJun 2006
Study completionJun 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Failed Moderate Sedation During ProcedureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02127489
Sponsor's protocol ID: B.30.2.KTU.0.01.00.01/372
Status last verified: Apr 2014
First submitted: 18 Apr 2014
Last updated: 30 Apr 2014
Results posted: No
Data monitoring committee: No

Publications

Mahajan R, Batra YK, Grover VK, Kajal J. A comparative study of caudal bupivacaine and midazolam-bupivacaine mixture for post-operative analgesia in children undergoing genitourinary surgery. Int J Clin Pharmacol Ther. 2001 Mar;39(3):116-20. doi: 10.5414/cpp39116.
PubMed 11396751
Breschan C, Schalk HV, Schaumberger F, Likar R. Experience with caudal blocks in children over a period of 3.5 years. Acta Anaesthesiol Scand Suppl. 1996;109:174-6. No abstract available.
PubMed 8901998
Sumpelmann R, Munte S. Postoperative analgesia in infants and children. Curr Opin Anaesthesiol. 2003 Jun;16(3):309-13. doi: 10.1097/00001503-200306000-00011.
PubMed 17021476
Lee HM, Sanders GM. Caudal ropivacaine and ketamine for postoperative analgesia in children. Anaesthesia. 2000 Aug;55(8):806-10. doi: 10.1046/j.1365-2044.2000.01330-2.x.
PubMed 10947698
Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9.
PubMed 16682915
Clausen TG, Wolff J, Hansen PB, Larsen F, Rasmussen SN, Dixon JS, Crevoisier C. Pharmacokinetics of midazolam and alpha-hydroxy-midazolam following rectal and intravenous administration. Br J Clin Pharmacol. 1988 Apr;25(4):457-63. doi: 10.1111/j.1365-2125.1988.tb03330.x.
PubMed 3382589
Kanegaye JT, Favela JL, Acosta M, Bank DE. High-dose rectal midazolam for pediatric procedures: a randomized trial of sedative efficacy and agitation. Pediatr Emerg Care. 2003 Oct;19(5):329-36. doi: 10.1097/01.pec.0000092578.40174.85.
PubMed 14578832
McGrath PJ, McAlpine L. Psychologic perspectives on pediatric pain. J Pediatr. 1993 May;122(5 Pt 2):S2-8. doi: 10.1016/s0022-3476(11)80002-8.
PubMed 8487132
Tyler DC, Tu A, Douthit J, Chapman RC. Toward validation of pain measurement tools for children: a pilot study. Pain. 1993 Mar;52(3):301-309. doi: 10.1016/0304-3959(93)90163-J.
PubMed 8460048
Shavit I, Keidan I, Augarten A. The practice of pediatric procedural sedation and analgesia in the emergency department. Eur J Emerg Med. 2006 Oct;13(5):270-5. doi: 10.1097/00063110-200610000-00005.
PubMed 16969231
Roy RC. Choosing general versus regional anesthesia for the elderly. Anesthesiol Clin North Am. 2000 Mar;18(1):91-104, vii. doi: 10.1016/s0889-8537(05)70151-6.
PubMed 10935002
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204
Somri M, Gaitini LA, Vaida SJ, Yanovski B, Sabo E, Levy N, Greenberg A, Liscinsky S, Zinder O. Effect of ilioinguinal nerve block on the catecholamine plasma levels in orchidopexy: comparison with caudal epidural block. Paediatr Anaesth. 2002 Nov;12(9):791-7. doi: 10.1046/j.1460-9592.2002.00916.x.
PubMed 12519139
Solak M, Ulusoy H, Sarihan H. Effects of caudal block on cortisol and prolactin responses to postoperative pain in children. Eur J Pediatr Surg. 2000 Aug;10(4):219-23. doi: 10.1055/s-2008-1072362.
PubMed 11034509
Golianu B, Krane EJ, Galloway KS, Yaster M. Pediatric acute pain management. Pediatr Clin North Am. 2000 Jun;47(3):559-87. doi: 10.1016/s0031-3955(05)70226-1.
PubMed 10835991

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Single-dose Rectal Midazolam Application on Post-operative Recovery, Sedation, and Analgesia in Children Given Caudal Anesthesia Plus Bupivacaine
ClinicalTrials.gov ID: NCT02127489
Acronym / sponsor ID: B.30.2.KTU.0.01.00.01/372
Conditions: Failed Moderate Sedation During Procedure
Keywords: Bupivacaine, caudal, rectal midazolam, children
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Karadeniz Technical UniversityUniversity, hospital or other
Study start: Jun 2005
Primary completion: Jun 2006 (actual)
Study completion: Jun 2006 (actual)
First posted: 30 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Midazolam	Active comparator	Drug: 1 mL/kg bupivacaine 0.25%.1 mL/kg bupivacaine 0.25%.
saline	Placebo comparator	Drug: 1 mL/kg bupivacaine 0.25%.5mL rectal saline

Who may qualify

Ages: 2 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

children having lower abdominal surgery

Key exclusion criteria (1 listed)

Children with significant respiratory system, circulatory system, liver, and kidney function disorder, history of allergy to the drugs to be studied, those who received analgesic medication before the operation, and those for whom caudal anesthesia is contraindicated

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1 mL/kg bupivacaine 0.25%.Also: AstraZeneca Marcaine40 children between 2 and 10 years of ASA I-II were randomized and they received caudal anesthesia under general anesthesia. Patients underwent the application of caudal block in addition with saline and 1 mL/kg bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5mL saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline. Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.	Drug	Midazolam, saline

Primary outcome

Sedation scale and postoperative pain scale (CHIPPS)
Time frame: 24 hours
Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
Background: PubMed 11396751Mahajan R, Batra YK, Grover VK, Kajal J. A comparative study of caudal bupivacaine and midazolam-bupivacaine mixture for post-operative analgesia in children undergoing genitourinary surgery. Int J Clin Pharmacol Ther. 2001 Mar;39(3):116-20. doi: 10.5414/cpp39116.
Background: PubMed 8901998Breschan C, Schalk HV, Schaumberger F, Likar R. Experience with caudal blocks in children over a period of 3.5 years. Acta Anaesthesiol Scand Suppl. 1996;109:174-6. No abstract available.
Background: PubMed 17021476Sumpelmann R, Munte S. Postoperative analgesia in infants and children. Curr Opin Anaesthesiol. 2003 Jun;16(3):309-13. doi: 10.1097/00001503-200306000-00011.
Background: PubMed 10947698Lee HM, Sanders GM. Caudal ropivacaine and ketamine for postoperative analgesia in children. Anaesthesia. 2000 Aug;55(8):806-10. doi: 10.1046/j.1365-2044.2000.01330-2.x.
Background: PubMed 16682915Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9.
Background: PubMed 3382589Clausen TG, Wolff J, Hansen PB, Larsen F, Rasmussen SN, Dixon JS, Crevoisier C. Pharmacokinetics of midazolam and alpha-hydroxy-midazolam following rectal and intravenous administration. Br J Clin Pharmacol. 1988 Apr;25(4):457-63. doi: 10.1111/j.1365-2125.1988.tb03330.x.
Background: PubMed 14578832Kanegaye JT, Favela JL, Acosta M, Bank DE. High-dose rectal midazolam for pediatric procedures: a randomized trial of sedative efficacy and agitation. Pediatr Emerg Care. 2003 Oct;19(5):329-36. doi: 10.1097/01.pec.0000092578.40174.85.
Background: PubMed 8487132McGrath PJ, McAlpine L. Psychologic perspectives on pediatric pain. J Pediatr. 1993 May;122(5 Pt 2):S2-8. doi: 10.1016/s0022-3476(11)80002-8.
Background: PubMed 8460048Tyler DC, Tu A, Douthit J, Chapman RC. Toward validation of pain measurement tools for children: a pilot study. Pain. 1993 Mar;52(3):301-309. doi: 10.1016/0304-3959(93)90163-J.
Background: PubMed 16969231Shavit I, Keidan I, Augarten A. The practice of pediatric procedural sedation and analgesia in the emergency department. Eur J Emerg Med. 2006 Oct;13(5):270-5. doi: 10.1097/00063110-200610000-00005.
Background: PubMed 10935002Roy RC. Choosing general versus regional anesthesia for the elderly. Anesthesiol Clin North Am. 2000 Mar;18(1):91-104, vii. doi: 10.1016/s0889-8537(05)70151-6.
Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
U.S. National Library of MedicineLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SEDAT SAYLAN, Med. doctor principal investigator

KANUNI EDUCATION AND RESEARCH HOSPITAL, TRABZON ,TURKEY

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 1 mL/kg bupivacaine 0.25%. in people with Failed Moderate Sedation During Procedure, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedation scale and postoperative pain scale (CHIPPS) (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02127489, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014; AzTrials last refreshed its copy on 2 Nov 2026.