Is an Only Child Clinical Trial
Official title:
Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
| Verified date | October 2017 |
| Source | Professor Fernando Figueira Integral Medicine Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 12 Years |
| Eligibility |
Inclusion Criteria: - Aged 2 - 12 Years. - Need for tonsillectomy / adenotonsillectomy. - Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or 3. - Anestesia geral com sevoflurano. - Use of Intraoperative dipyrone, 30-50mg/Kg, IV. Exclusion Criteria: - Changes in consciousness. - Neurological Deficit. - Use of another drug as medication before anesthesia. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) | Recife | Pernambuco |
| Lead Sponsor | Collaborator |
|---|---|
| Professor Fernando Figueira Integral Medicine Institute |
Brazil,
Fazi L, Jantzen EC, Rose JB, Kurth CD, Watcha MF. A comparison of oral clonidine and oral midazolam as preanesthetic medications in the pediatric tonsillectomy patient. Anesth Analg. 2001 Jan;92(1):56-61. — View Citation
Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. Review. — View Citation
Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page. — View Citation
Malviya S, Voepel-Lewis T, Ramamurthi RJ, Burke C, Tait AR. Clonidine for the prevention of emergence agitation in young children: efficacy and recovery profile. Paediatr Anaesth. 2006 May;16(5):554-9. — View Citation
Silva LM, Braz LG, Módolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: doi:10.2223/JPED.1763. Review. — View Citation
Tazeroualti N, De Groote F, De Hert S, De Villé A, Dierick A, Van der Linden P. Oral clonidine vs midazolam in the prevention of sevoflurane-induced agitation in children. a prospective, randomized, controlled trial. Br J Anaesth. 2007 May;98(5):667-71. E — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postoperative agitation | Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED). | 6 hours | |
| Secondary | Duration of postoperative agitation | Time in minutes. | 6 hours | |
| Secondary | Need for post-anesthetic drugs for treatment of agitation | Use of any drugs, such as sedatives, opioids, anti-inflammatory or anti-emetic for improvement agitation. | 6 hours | |
| Secondary | Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters | If any accident occurs in the recovery room, and postoperative (falls, bruises) disconnection of intravenous catheter or injuries. | 6 hours | |
| Secondary | Drowsiness | Clinical evaluation: patient awake, awake, alert or patient under hypnosis. | 6 hours | |
| Secondary | Parental satisfaction. | As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital. | 24 hours |