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Tonsillectomy clinical trials

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NCT ID: NCT01198210 Recruiting - Tonsillectomy Clinical Trials

The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy

Start date: July 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The immediate postoperative period after tonsillectomy, , is often difficult. These children frequently have severe pain but postoperative airway edema along with increased sensitivity to the respiratory-depressant effects of opioids may result in obstructive symptoms and hypoxemia. Opioid consumption may be reduced by non-steroidal anti-inflammatory drugs, but these drugs may be associated with increased bleeding after this operation. Methods: One hundred sixty ASA I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy. Study drugs were marked only with a coded number label. A computer-generated table of numbers guided randomization. Modified Hannallah pain scale [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients were interviewed on the day after surgery to assess the postoperative pain, nightmares, hallucinations, vomiting and bleeding. All the children were premedicated with midazolam hydrochloride 0.3 mg/kg) and fentanyl 1micro g/kg intavenously. Anesthesia was induced with thiopental 5mg/kg and atracurium0.3mg/kg. Anesthesia was maintained with isoflurane 1.5% and nitrous oxide 30% in oxygen. The two surgeon used the same dissection and snare technique for all cases and hemostasis done with bipolar cutter. At the end of the surgery neuromuscular blockade was reversed by neostigmine 0.03 mg/kg) and atropine 0.01 mg/kg intravenously), anesthesia was discontinued and the tracheal tube removed in the operating room when patients were deep. After extubation the patients were taken to the postanesthesia care unit (PACU) where an nurse who were unaware of the study drug observed the patients. The pain scoring observer nurse in PACU was consistent. Time to awaken (from the end of anesthesia until the patients opened their eyes on command) and time to the first administration of postoperative analgesia were recorded. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients with a OPS score > 4 or who were crying during two consecutive five minute observation periods until the child was comfortable. Postoperative pain during the first 24 h was assessed using a four-point scale: 0 no pain, 1 mild pain, 2 moderate pain, 3 severe pain by questioning their parents. In the ward the standardized postoperative analgesic technique was with acetaminophen supp (40 mg/kg followed by three doses of 20 mg/kg at 6-hour intervals to be given as needed for pain. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients who had pain scale >3.Any supplementary analgesia , nausea and vomiting, bleeding, sleep disturbance and nightmares that the child might have had as surgery were assessed during a telephone follow up 24 h later.

NCT ID: NCT01141660 Completed - Tonsillectomy Clinical Trials

Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Start date: December 2007
Phase: N/A
Study type: Interventional

The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.

NCT ID: NCT00849966 Completed - Pain, Postoperative Clinical Trials

Celecoxib for Pediatric Adenotonsillectomy

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The investigators' study will involve the administration of either placebo or celecoxib to children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief, impact on quality of life and side effect profile.

NCT ID: NCT00836264 Completed - Pharmacokinetics Clinical Trials

Pharmacogenomics Analysis of Morphine Pharmacokinetics in Pediatric Tonsillectomy and Adenoidectomy

Start date: January 2009
Phase:
Study type: Observational

Intravenous (IV) morphine requirement for immediate postoperative pain control depends upon the complex interplay of patient history, wound severity, environment, and genetics. Even for relatively uniform stimulus intensity, such as that associated with tonsillectomy and adenoidectomy (T&A), there can be marked individual variability in response to morphine. Some patients are refractory to standard doses and need increased amounts. Others are sensitive, require less drug to attain acceptable pain levels, and/or experience unwanted side effects that limit dosing. A significant number must be switched to different analgesics altogether. Despite the long clinical history of morphine as a postoperative analgesic, researchers have only begun to examine the origins of response variability. The investigators will look at 2000 retrospective Tonsillectomy and Adenoidectomy (T&A) cases and using this data and incorporating additional patient, surgical, and environmental factors that may contribute to response variability, the investigators then propose a prospective genome-wide association (GWA) study of 1500 children ages 4 to 18 years treated with IV morphine sulfate for day surgery T&A.

NCT ID: NCT00756873 Not yet recruiting - Tonsillectomy Clinical Trials

Etoricoxib in Ear Nose Throat Surgery

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The aim of this study is to test the analgesic efficacy of etoricoxib (90 mg or 120 mg qd. perioperatively) for post-operative pain relief. The primary endpoint is as follows: - does preoperative etoricoxib reduce the post-operative opioid utilization in patients undergoing elective tonsillectomy under general anaesthesia (i.e. the post-operative opioid-sparing effect of etoricoxib in humans). The secondary endpoints are as follows: - does the etoricoxib medication have an impact on PONV or activities of daily - does the etoricoxib medication influence the blood loss during surgery or the incidence of postoperative bleeding - does the etoricoxib medication influence the operation time. In addition, adverse effects of etoricoxib will be documented.

NCT ID: NCT00730340 Completed - Children Clinical Trials

Closure Method Study Following Tonsillectomy in Children

Start date: August 2008
Phase: Phase 0
Study type: Interventional

This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.

NCT ID: NCT00662987 Completed - Tonsillectomy Clinical Trials

Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Start date: September 2005
Phase: N/A
Study type: Interventional

To determine whether a 3-day course of postoperative antibiotics is effective as a 7-day course in reducing pain and reducing time to resumption of normal diet and activity following pediatric tonsillectomy

NCT ID: NCT00581139 Completed - Pain, Postoperative Clinical Trials

Psychological Influences on Postoperative Recovery

NIH
Start date: April 2003
Phase: Phase 2
Study type: Interventional

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.

NCT ID: NCT00273754 Completed - Clinical trials for Postoperative Complications

The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).

OSA
Start date: September 2003
Phase: Phase 2
Study type: Interventional

This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).

NCT ID: NCT00251628 Completed - Tonsillectomy Clinical Trials

Home Care Management of Pediatric Pain

Start date: June 2000
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether around-the-clock dosing of pain medication, with or without nurse coaching, increases the effectiveness of pain management (i.e., decreased pain intensity scores with and without swallowing, increased use of pain medication, improved sleep, increased oral intake of fluids, decreased negative behaviors, and the same degree of side effects), over time, compared to standard care with "as needed" dosing.